Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04808232 |
| Other study ID # |
168846 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2019 |
| Est. completion date |
April 2, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
Gazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
