The Effect of Health Education and Progressive Muscle Relaxation Exercise on Vasomotor Symptoms and Sleep Problems With Perimenopausal Women
Condition: Vasomotor Symptoms; Hot Flashes; Sleep Problem
MeSH terms: Dyssomnias; Parasomnias; Sleep Wake Disorders; Hot Flashes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
      Garcia et al. (2018) (Garcia et al., 2018).

      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.
    

Intervention name(s): progressive muscle relaxation exercise
Intervention type(s): Behavioral
Intervention description(s): We used "the muscle relaxation audio CD" produced by the Turkish Psychologists Association. The CD consists of three parts; the 10-min first part includes definition and purpose of relaxation, and points to take into consideration during relaxation, the 30-min second part includes instructions with river sounds, and the 30-min third part includes only relaxing music without instructions. We used the second part of the audio record in this study. Following the instructions on the CD, the students tensed each muscle group from hands to feet, and then, all muscles in their face and body for approximately 10 s. The women breathed in, tensed a specific muscle group, and then relaxed it while breathing out. The relaxation step took 10-20 s before tensing the next muscle group. Thus, the women relaxed by tensing and relaxing the muscle groups in hands, arms, neck, shoulder, chest, stomach, hips, foot and fingers, and all muscles in the face and body.
Other intervention name(s): health education
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vasomotor symptoms,; sleep problems,; health education,; progressive muscle relaxation exercise