The Effect of Health Education and Progressive Muscle Relaxation Exercise on Vasomotor Symptoms and Sleep Problems in Women With Perimenopausal Period

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.