The Effect of Health Education and Progressive Muscle Relaxation Exercise on Vasomotor Symptoms and Sleep Problems With Perimenopausal Women
The Effect of Health Education and Progressive Muscle Relaxation Exercise on Vasomotor Symptoms and Sleep Problems With Perimenopausal Women
This study aims to determine the effect of health education and progressive muscle relaxation
 exercise (PMRE) on vasomotor symptoms and sleep problems in women with perimenopausal period;
 a randomized, pretest-posttest is a randomized controlled, factorial group experimental
 study. The research was conducted in a family health center. The required institutional
 permission and ethics committee approval was received. The sample consisted of 90 women
 totally, 30 of whom in the PMRE + health education group, 30 of whom in the PMRE group and 30
 of whom in the control group. The data was collected using personal information form, Visual
 Analog Scale for Vasomotor Symptoms (VAS), Women's Health Initiative Insomnia Rating
 Scale-WHIIRS, vasomotor symptom diary, progressive muscle relaxation exercise follow-up
 schedule, and health education practice follow-up schedule. The data were stored in the SPSS
 24 program. In the analysis of the data, ANOVA test, Repeated Measures test, Kruskal-Wallis H
 test, Friedman test and χ2 test statistics were used.
Purpose and type of study The study examines the effects of health education and progressive
 muscle relaxation exercise (PMRE) on vasomotor symptoms and sleep problems in women in the
 perimenopausal period; pretest-posttest is a randomized controlled, factorial group
 experimental study.

 Universe and sample The research was conducted in a family health center. The required
 institutional permission and ethics committee approval was received. The universe of the
 research consists of 1830 women between the ages of 40-55 registered at Gazi Family Health
 Center. A pilot application was conducted to determine the sample size in the study. Power
 analysis was performed using the G * Power 3.0.10 program with 18 women (PMRE + Health
 education group (n = 6), PKGE group (n = 6), control group (n = 6)) who took part in the
 pilot study. According to the power analysis performed by calculating the effect size
 (0.177), the sample size calculated with 90% power and 5% margin of error; A total of at
 least 84 women were identified, including 28 women in the PMRE + Health education group, 28
 women in the PMRE group and 28 women in the control group. Similar to our study, 36 women
 were included in each group in our study by calculating the drop-out rate in the study of
 Fenlon et al. (2008) (Fenlon et al., 2008).

 The data collection process of the research started on 17.02.2019 and the determined sample
 number was completed on 02.04.2020. In this process, women who applied to ASM between
 17.02.2019-23.01.2020 and who met the sampling criteria and accepted to participate in the
 study after the purpose and importance of the study were explained were determined. Under the
 direction of the researcher, the women interviewed a nurse independent of the study. Nurse
 The inclusion criteria used the check-list form to evaluate the compliance of the women with
 the research criteria. Personal information form, vasomotor symptom VAS and Women's Health
 Initiative Insomnia Scale-WHIIRS (pre-tests) were applied to determine compliance with the
 criteria. After the women meeting the criteria were informed about the study and consent was
 obtained, randomization was performed. During the study, a total of 482 women who applied to
 family health center were interviewed. Of these women; non-perimenopausal (n = 20), surgical
 menopause (n = 17), using psychiatric drugs and sleeping pills (n = 62), using alcohol (n =
 14), women health initiative insomnia scale score below 10 (n = 78), the severity score of
 VAS symptoms for vasomotor symptoms is less than 3 (n = 69), who received hormone replacement
 therapy (n = 27), the number of moderate and severe hot flashes per day (n = 67), and A total
 of 374 women who did not agree to participate in the study (n = 20) were not included in the
 study. A total of 108 women who met the research criteria were stratified according to their
 smoking and regular exercise status. After stratification, women were assigned to the groups
 by simple randomization method (closed envelope method). For this purpose, three different
 envelopes were formed by placing the cards with A, B and C in the envelopes. A: PMRE + Health
 education group, B: PMRE group, C: represent the control group. In order to prevent bias and
 hide randomization, random assignments were made to the groups by the nurses using the closed
 envelope method. According to the envelope result, women were included in the PMRE + Health
 education group, the PMRE group and the control group. The study sample included women in the
 PMRE + Health education group (n = 36), the PMRE group (n = 36), and the control group (n =
 36). Women participated in the practices prepared for the groups they were included in. Six
 of the women in the PMRE + Health education group participated in the training, but were
 excluded from the sample due to moving (n = 2), death of a relative (n = 1), illness (n = 1)
 and not doing PMRE in sufficient numbers (n = 2). Six of the women in the PKGE group
 participated in the training, but were excluded from the sample due to the death of the
 relative (n = 1) and the illness (n = 2) not making PKGE sufficiently (n = 3). Six women in
 the control group were excluded from the sample because they would voluntarily (n = 4) and
 start a new job (n = 2). As a result; A total of 18 women included in the sample left the
 study, the study was completed with women in the PKGE + Health education group (n = 30), the
 PMRE group (n = 30), and the control group (n = 30). At the end of the research; As a result
 of the power analysis made using the G * Power 3.0.10 program; At least 90 women in total
 were found to be sufficient with 90% power, 5% margin of error and 0.172 effect size.The data
 was collected using personal information form, Visual Analogue Scale for Vasomotor Symptoms
 (VAS), Women's Health Initiative Insomnia Rating Scale-WHIIRS, vasomotor symptom diary,
 progressive muscle relaxation exercise follow-up schedule, and health education practice
 follow-up schedule.

 Randomization In our study, support was received from a statistician during the randomization
 phase. The stratified sampling method was applied over these two prognostic factors to ensure
 randomization, as it is thought that smoking (smoker and non-smoker) and regular exercise
 (regularly exercising and not exercising regularly) may affect our study results. After
 stratification; A total of four groups were determined according to the layer properties.

 Four stratum groups were formed to ensure equal distribution of women in terms of smoking and
 regular exercise in the experimental and control groups in the study. The closed-envelope
 method was used to assign stratified women to the control and experimental groups without
 being biased, and an equal number of women were assigned to each group. During the
 preparation of envelopes, opaque envelopes are used to prevent the inside of the envelope
 from being seen from the outside. The envelopes were created by a nurse working at the Family
 health center, independent of the research. Three different envelopes were formed by placing
 the cards A, B and C in the envelopes. A: PMRE + Health education group, B: PMRE group, C:
 represents the control group. In order to prevent bias and conceal randomization, women were
 randomly assigned to the groups by a sealed envelope method by a second nurse working at
 family health center outside the researcher. The nurse placed women who met the research
 criteria in the appropriate strata from four strata. When groups of three people were formed
 in each stratum, the women from the strata were assigned to the groups as follows. He asked
 the first woman with the same characteristics to come to each stratum group to pull one of
 the three envelopes marked A, B, and C. For example: If C is in the envelope, the first woman
 who came was assigned to the control group. For the second woman, she was asked to pull one
 of the two envelopes, this time marked A and B. If A was placed in the draw, the second woman
 was assigned to the PMRE + Health education group. The envelope was not drawn for the third
 woman who came, and she was assigned to the last remaining group, the PMRE group. The same
 method was applied for all three women in the same layer after that.

 Thus, 108 women in the sample were randomly assigned to the PMRE + Health education group,
 the PMRE group and the control groups stratified and equally. Until the initiatives started,
 the groups to which the women were assigned were not known to the researchers. The
 homogeneity of the randomized groups was compared with the chi-square test and it was found
 that there was no statistical difference between the groups in terms of stratification
 criteria, and the groups were homogeneous.

 Prevention of bias In the study, women in the PMRE + Health education group and the PMRE
 group could not be blinded because they will participate in the training. In order to prevent
 bias, women were informed, assigned to groups and data were collected by a nurse outside of
 the study. However, the study was carried out by the researcher because the research was a
 thesis study, the number of application groups was high, multiple attempts were applied and
 the application should be done by an experienced researcher. For these reasons, the
 researcher could not be blinded. Prevention of bias in the research (in terms of data
 collectors, statistician and reporting) has been done. The pre and post-tests were filled by
 a nurse independent of the research. The collected data were coded as A, B and C groups by
 the researcher in a package program called SPSS (IBM SPSS Statistics 24). The analysis of the
 data coded in terms of groups was done and reported by a statistician. In this way, detection
 bias, statistical bias, and reporting bias were controlled.

 Data collection and application process

 1. st evaluation (conducted in the 1st week) The women who applied to the family health
 center and met the sampling criteria and accepted to participate in the study after the
 purpose and importance of the study were explained were determined. The women were
 informed about the research by the nurse with the direction of the researcher. Nurse
 'The inclusion criteria used the check-list form to evaluate the compliance of the women
 with the research criteria. It was ensured that women filled the personal information
 form, vasomotor symptom VAS and Women's Health Initiative Insomnia Scale, which are
 necessary to determine compliance with the criteria. The nurse placed the women who met
 the criteria in the appropriate strata from four strata. When groups of three people
 were formed in each stratum, women were assigned to the groups as follows. He asked the
 first woman with the same characteristics to come to each stratum group to pull one of
 the three envelopes marked A, B, and C. For example; If C is in the envelope, the first
 woman arriving was assigned to the control group. For the second woman, she was asked to
 pull one of the two envelopes, this time marked A and B. If A was placed in the draw,
 the second woman was assigned to the PMRE + Health education group. The envelope was not
 drawn for the third woman who came, and she was assigned to the last remaining group,
 the PMRE group. The same method was applied for all three women in the same layer after
 that. Thus, women were randomly assigned to the study groups.

 Following this, a vasomotor symptom diary was given to all women by the nurse. The women
 assigned to the PMRE + health education group and the PMRE group were asked to complete
 the vasomotor symptom diary every day for a week until a training class would be
 established one week later and up to this training class. The women in the control group
 were instructed to fill in the vasomotor symptom diary until the end of the study. The
 averages in the diary filled in the first week of all women formed the baseline data
 before starting the study.

 Establishment of PMRE + health education and PMRE education classes (1st week was held)
 When small groups of 3 people are formed in the stratification groups and 3 women are
 appointed to the working groups, by taking name lists from the nurse; The researcher
 interviewed women. In these meetings; An explanation and planning were made for the
 groups to be intervened about the training day, place, time, duration, and wearing
 appropriate/comfortable clothes. At the beginning of the second week of the study, a
 time frame between 13.00-16.00 was determined to be suitable for the researcher and all
 three women in his group. In PMRE + Health education and PMRE group, training was given
 in groups of three (12 groups + 12 groups = 24 groups). The application was made in a
 room allocated for research in the family health center. This room is quiet, dim, and
 spacious. There are seats and a table for women and the researcher. Considering the
 capacity of this room, it was decided that it would be appropriate for the groups to
 have three people in order for women to participate in health education more actively
 and the researcher could observe each woman performing PMRE in detail. The women were
 asked to attend the training in comfortable clothes and not to be very hungry or full.
 The hall is pre-ventilated for the application and the application environment has been
 prepared. In order not to be disturbed during the application, a warning letter is hung
 on the door. Participants were offered water during the training sessions, tea,
 chocolate, sweets, dried fruits, cakes, etc. after the application.

 Training the PMRE + health education group (2nd week) Each group was provided with
 health education (training on vasomotor symptoms and sleep hygiene) and PMRE practice
 training. Health education (training on vasomotor symptoms and sleep hygiene) lasted
 approximately 30 minutes. Then, the gradual muscle relaxation exercise was performed by
 the researcher in line with the musical instruction prepared by the Turkish
 Psychologists Association (01.01.2010) for 30 minutes. After an interval of
 approximately 10 minutes, PMRE was performed by women for approximately 30 minutes.

 The training started with health education (training on vasomotor symptoms and sleep
 hygiene). The researcher will spend about 30 minutes with a slide show prepared in
 accordance with the content of the educational guide. He gave training. During and after
 the training, questions from women were answered, women's own experiences were shared,
 and they were talked about how to apply education to their daily lives. The questions of
 women who were hesitant about this issue or who thought they might have trouble at the
 point of the application were answered. Participants in the training were given a
 booklet titled "A Guide to Coping with Hot Flashes, Night Sweats, and Sleep Problems
 Frequently Encountered in the Transition to Menopausal Period" prepared by the
 researchers. At the end of the training, the women were asked to apply the topics of
 health education to their daily lives as much as possible every day for 8 weeks, if not
 at least 4 days a week. It was stated that those who do not comply with this program
 will be excluded from the sample.

 The researcher first demonstrated the PMRE application by doing it himself and then
 enabled the participants to practice. All participants were observed by the researcher
 during the learning process and they were ensured to apply progressive muscle relaxation
 exercises correctly. At the end of the exercise, the women were asked to do relaxation
 exercises every day if possible for 8 weeks, at least 4 times a week when this was not
 possible, before going to sleep at night. The musical instructions for the gradual
 relaxation exercise were uploaded to the phones of all women. Feedback was obtained from
 the women after the first exercise alone and the questions were answered. Thus, women
 were provided to do the application correctly.

 A Whatsapp® group was established for each 3-person training group in order to monitor
 and encourage women to exercise health education and exercise. The women were asked to
 report from this group when they adapted their health education to their daily lives and
 after applying the exercise. Throughout the study, the women were reminded to adapt
 health education and exercise every day from the Whatsapp® group, and women who did/did
 not practice the application were identified with their feedback.

 At the end of the training given by the researcher, the women were given a vasomotor
 symptom diary, PMRE follow-up chart, and health education follow-up chart to fill in
 until the end of the study. Women marked their practices on the health education
 follow-up chart and progressive muscle relaxation exercise follow-up chart for 8 weeks.
 This marked chart was retrieved from the participants at the end of the 8-week practice.

 2. nd evaluation (made in the 5th week) Four weeks after the PMRE + health education, women
 were made to fill the Women's Health Initiative Insomnia Scale and the visual analog
 scale for vasomotor symptoms for the second time by the nurse. They were reminded to
 continue filling out the diary and charts until the research was completed.

 3. rd evaluation (conducted at the 9th week)

 8 weeks after the PMRE + health education, the nurse was asked to fill the Women's Health
 Initiative Insomnia Scale and the visual analog scale for vasomotor symptoms for the third
 and last time. The diaries and charts they filled out were taken and filed, and the research
 was terminated. The data were collected as specified in the application calendar.

 Training the PMRE group (2nd week) Only women in the PMRE group were taught how to perform
 PMRE. Approximately 30 minutes, the gradual muscle relaxation exercise was applied by the
 researcher in accordance with the musical instruction prepared by the Turkish Psychological
 Association (01.01.2010). Then, women were allowed to apply PMRE for approximately 30
 minutes.

 All participants were observed by the researcher during the learning process and they were
 ensured to apply progressive muscle relaxation exercises correctly. At the end of the
 exercise, the women were asked to do relaxation exercises every day if possible for 8 weeks,
 at least 4 times a week when this was not possible, before going to sleep at night. The
 musical instructions for the gradual relaxation exercise were uploaded to the phones of all
 women. Feedback was obtained from the women after the first exercise alone and the questions
 were answered. Thus, women were provided to do the application correctly.

 In order to monitor and encourage women to do PMRE, a Whatsapp® group was established for
 each 3-person training group. The women were asked to report from this group after applying
 the exercise. Throughout the study, women were reminded to do the exercise every day, and
 women who did/did not do it were identified with their feedback.

 At the end of the training given by the researcher, the women were given a vasomotor symptom
 diary and PCI follow-up chart to fill in until the end of the study. Women marked their
 practices on the Progressive Muscle Relaxation Exercise Follow-up Chart for 8 weeks. This
 marked chart was retrieved from the participants at the end of the 8-week practice.

 2nd evaluation (conducted at the 5th week) Four weeks after the training, women were made to
 fill the Women's Health Initiative Insomnia Scale and the visual analog scale for vasomotor
 syndromes for the second time by the nurse at the Family health center. They were reminded to
 continue filling out the diary and charts until the research was completed.

 3rd evaluation (conducted at the 9th week) 8 weeks after the training, women were provided to
 fill the Women's Health Initiative Insomnia Scale and the visual analog scale for vasomotor
 symptoms for the third and last time by the nurse at the family health center. The research
 was concluded by taking the diary and charts they filled out. The data were collected as
 specified in the application calendar.

 Control group

 1. st evaluation (conducted in the 1st week) In the first evaluation, women were made to
 fill in the personal information form, vasomotor symptom VAS, and the Women's Health
 Initiative Insomnia Scale. After the pre-tests were applied, random assignments were
 made to the groups. Following this, a vasomotor symptom diary was given to women in the
 control group by the nurse. They were instructed to fill in the vasomotor symptom diary
 until the end of the study. No intervention was applied to the women assigned to the
 control group as a result of randomization.

 2. nd evaluation (conducted at the 5th week) The nurse made it possible for women to fill
 the Women's Health Initiative Insomnia Scale for the second time and the visual analog
 scale for vasomotor symptoms. They were reminded to continue filling in the diary until
 the end of the study.

 3. rd evaluation (conducted at the 9th week) women were provided to fill the Women's Health
 Initiative Insomnia Scale and the visual analog scale for vasomotor symptoms for the
 third and last time by the nurse. The research was terminated by taking the diaries they
 filled. The data were collected in accordance with the application schedule.

 The data were stored in the SPSS 24 program. In the analysis of the data, ANOVA test,
 Repeated Measures test, Kruskal-Wallis H test, Friedman test, and χ2 test statistics were
 used.
Inclusion Criteria:

 -  Being in the perimenopausal period according to the Staging of Reproductive Aging in
 Women (STRAW) criteria,

 -  Women in the early menopause transition phase (STRAW -2). In these women, there
 is a variation in the duration of the cycles for 7 days or more.

 -  Women in the late menopausal transition phase (STRAW -1). These women have
 amenorrhea that lasts 60 days or longer.

 -  Having entered natural menopause,

 -  Not receiving hormone replacement therapy in the past and / or currently,

 -  Not having a diagnosed psychiatric disease,

 -  Not using alcohol,

 -  Not using sleeping pills,

 -  Not doing any other body-mind based practice (meditation, hypnosis, yoga, mindfulness
 techniques-minfulness, guided imagery technique), Not having a disease that may cause
 sleep problems and vasomotor symptoms and not receiving medical treatment (thyroid
 diseases, heart failure, neurological disorders),

 -  Women health initiative insomnia scale score above 10,

 -  VAS severity score above 3 for vasomotor synptomes,

 -  Number of moderate and severe hot flashes over 3 a day,

 -  To have a smart mobile phone (IOS and Android) and to be using it effectively

 Exclusion Criteria:

 -  Failure to communicate by calling 3 times on different days during the follow-up and
 the woman not returning to the phone call

 -  Woman not applying PMRE and health education at most 3 times a week

 -  The woman leaves the research voluntarily.