AzTrials
AzTrials

Therapeutic TouchNCT05977426

The Effects of Reiki on Menopausal Symptoms and Depression Levels

A study testing Reiki in people with Therapeutic Touch and Menopausal Symptoms, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Therapeutic Touch, Menopausal Symptoms
What is being tested?
Reiki
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2023to 23 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,
  • did not take hormone replacement therapy.

Who cannot join

  • having a diagnosis of any psychiatric illness

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Esra Sabanci Baransel

    Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Reiki on Menopausal Symptoms and Depression Levels in the Postmenopausal Period: A Randomized Clinical Trial

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.

Read the detailed 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.

Being tested
Reiki
Keywords
Reiki, menopause, menopausal symptoms, depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReikiOther

    In the study, women received four Reiki sessions once a week for four weeks from the researchers with Usuı Shiki Ryoho Reiki 1

Study groups in NCT05977426
Study groupRoleWhat they receive
ReikiExperimentalA sociodemographic questionnaire including questions about age, last menstrual period, education level and income level, Menopause Rating Scale (MRS), Beck Depression Inventory (BDI) were utilized for the collection of research data. 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). Data were collected from women who applied to the FHC for general healthcare services after receiving service. Women in the experimental group received Reiki once a week for four weeks. No initiative was applied to the pregnant women in the control group. Each session lasted 30-40 minutes. 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.
Receives: Other: Reiki
Routine checksNo interventionThe researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms(A sociodemographic questionnaire including questions about age, last menstrual period, education level and income level, Menopause Rating Scale (MRS), Beck Depression Inventory (BDI)). The post-test forms (MRS, BDI) were re-administered 4 weeks later to women who did not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Menopause Rating Scale (MRS)

    The Menopause Rating Scale (MRS) assess the severity of menopausal symptoms. 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.

    Measured: Change from menopause symptoms levels at 4 weeks

Secondary outcomes (1)
  1. Beck Depression Inventory (BDI)

    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. 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.

    Measured: Change from depression levels at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start1 May 2023
  3. Primary completion1 Jun 2023
  4. Study completion23 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
This study was designed as a randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05977426
Sponsor's protocol ID
2023/4577
Status last verified
Aug 2023
First submitted
25 Jul 2023
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Reiki in people with Therapeutic Touch and Menopausal Symptoms, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopause Rating Scale (MRS) (time frame: Change from menopause symptoms levels at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in