Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05977426 |
| Other study ID # |
2023/4577 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
July 23, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: This study was conducted to determine the effects of Reiki applied to women in the
postmenopausal period on menopausal symptoms and depression levels.
Methodology:This randomized controlled study was conducted with postmenopausal women
registered in a family health center in eastern Türkiye. The sample of the study consisted of
82 women, 41 in the Reiki group and 41 in the control group. While four sessions of Reiki
were applied to the women in the Reiki group, once a week for 4 weeks, no intervention was
applied to the control group. Menopause Rating Scale (MRS) and Beck Depression Inventory
(BDI) were used to collect data.
Description:
Design This study was designed as a randomized controlled trial in which participants were
randomly assigned to Reiki or control groups.
Location and time The study was conducted with postmenopausal women registered at a Family
Health Center (FHC) located in the center of a province in eastern Türkiye between May 2023
and July 2023. The center is a primary healthcare institution that provides general
healthcare services and reproductive healthcare services (such as family planning, education,
and counseling). There is no application specific to the menopausal period in the center.
This center was randomly selected considering its socioeconomic level, proximity to the city
center, and the number of women registered in the center. The center serves approximately
15.000 individuals, of which approximately 5100 are women. In addition, there was a quiet and
calm hall in the center where Reiki could be practiced.
Population and sample of the study The population of the study consisted of postmenopausal
women registered to the determined FHC. Women who applied to the FHC for any reason, agreed
to participate voluntarily, and met the inclusion criteria were included in the study. The
criteria for inclusion in the study were as follows: Those who were between the ages of
45-55, did not have hearing problems, did not have any psychiatric diseases, were in a
natural menopause period, and did not take hormone replacement therapy.
A web-based software was used to determine the sample size. Priori-power analysis was
performed to estimate the appropriate sample size. In the literature, the mean score of
menopausal symptoms, which is the primary result of the study, was found to be 16.6 (standard
deviation 8.9). The sample size was calculated as 41 for each group (41 Reiki group, 41
control group), assuming a 5% error level, bidirectional significance level, 95% confidence
interval, 80% representation of the population, and assuming to create a decrease in the
post-intervention menopausal symptoms mean score by 5 points.
To reach the sample size, 140 women were evaluated in terms of eligibility criteria. 47 women
who did not meet the inclusion criteria and 19 women who refused to participate in the study
were excluded from the study. 7 out of 50 women included in the Reiki group were excluded
from the study because they did not continue the sessions after the second Reiki session.
Seven of the 53 women included in the control group were excluded from the study because they
did not want to continue the study. The research was completed with a total of 82 women, 41
of them in the Reiki group and 41 of them in the control group.
Randomization The allocation of women to the Reiki and control groups in the study was done
by simple randomization. For randomization, using the random number generation method
available on the random.org site, numbers in which the numbers 1 and 2 are randomly sorted
were created in the system. Women who accepted to participate in the study and met the
inclusion criteria were randomly assigned to number 1 or 2 according to the order of arrival
at the FHC. Which number would be the Reiki or control group was determined by drawing lots
before starting the study. Number 1 formed the Reiki group, number 2 formed the control
group. The same method was continued until the women in the Reiki and control groups reached
the sample size.
Data collection tools In the study, data were collected with a sociodemographic questionnaire
including questions about age, last menstrual period, education level and income level,
Menopause Rating Scale (MRS), Beck Depression Inventory (BDI), and a question investigating
the level of being affected by menopause complaints. The question investigating the level of
being affected by menopause is: "At which level do menopause complaints affect you?". Women
answered this question on a scale of 0 (very little/very slightly) to 10 (extreme/very much).
The Menopause Rating Scale (MRS) was developed to assess the severity of menopausal symptoms.
The Turkish validity and reliability of the scale was performed in 2005. The scale consists
of 11 items and 3 subscales. These 3 subscales are called somato-vegetative complaints (such
as night sweating and hot flush), psychological complaints (such as anxiety and depression),
and urogenital complaints (such as urethral syndrome and vaginal dryness). The scale is in
the form of a 5-point Likert type and each item is graded between zero (no complaints) and
four (severe symptoms) points. The total score that can be obtained from the scale varies
between 0-44 points. An increase in the total score obtained from the scale indicates that
the menopausal complaints experienced are intensified. The Cronbach's alpha reliability
coefficient of the scale was calculated as 0.84.
Beck Depression Inventory (BDI) is used to have information about depressive symptoms and
attitudes by evaluating the findings of emotional, cognitive, and motivational symptoms that
can be seen in depression. The Turkish validity and reliability study of the inventory was
carried out. Depressive symptoms and attitudes were collected under 21 headings (moodiness,
pessimism, sense of failure, joylessness, sense of guilt, sense of punishment, self-blame,
suicidal ideation, desire to cry, level of irritability, social loneliness, indecision,
change in body image, inability to work, sleep disorder, fatigue, loss of appetite, weight
loss, somatic complaints, and loss of libido). Each item is scored between 0 (not at all) and
3 (severe) according to the severity of the displayed behavior. The lowest score that can be
obtained from the inventory is 0, and the highest score is 63. A high total score indicates a
high level of depression severity. The Cronbach's alpha reliability coefficient of the scale
was determined as 0.80.
Data collection In the study, data were collected from women who applied to the FHC for
general healthcare services after receiving service. After being informed about the research
by the researcher ESB, data collection tools were applied to the volunteer women in a hall in
the FHC by face-to-face interview method. Four weeks after the data collection tools used in
the research were filled in as a pre-test, post-test data were obtained with the same
measurement tools.
Intervention The Reiki intervention was administered free of charge by the ESB from
researchers holding a Usui Shiki Ryoho Reiki 1 (Degree 1) in the study. The researcher
received training and certification in Reiki techniques before starting the study. After
completing the training program, the researcher applied Reiki to the Reiki group once a week
for 4 weeks. The sessions were held individually in a hall in the ASM, taking into account
the times available to the women in the sample. Each session lasted 30-40 minutes. The Reiki
application in the study was based on the First Degree Reiki (Reiki I) protocol. In Reiki I,
the "aura attunement" between the practitioner and the person provides healing by touching or
holding the hands a few cm above the body. The following sequence is generally applied in the
Reiki protocol. 1. Before starting Reiki, the jewelry on the practitioner and the participant
is removed. 2. The person sits or lies down in a comfortable position. The arms and legs
remain open so that they do not touch each other. 3. Keeping the practitioner's fingers in a
comfortable position, energy is sent to each chakra or area on the body for 3-5 minutes. 6.
Hands are washed. In addition to the general protocol of reiki, the practitioner preferred a
quiet room and dimmed the light of the room to prevent distraction and practiced in a dim
environment. No intervention was applied to the control group by the researcher. Women in the
control group received the service they needed from ASM.
