PostPartum DepressionNCT06364436
Distant Reiki Therapy on Postpartum Period Fatigue and Depression
A study testing Reiki energy therapy in people with PostPartum Depression, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PostPartum Depression
- What is being tested?
- Reiki energy therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 26 Jun 2024
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were 18 years of age or older
- At least a primary school graduate
- Primiparous and multiparous, with a full-term (between 38-40 weeks) and healthy newborn
- Without any acute or chronic health problems, without communication problems that could answer the data collection tools used in the study
- Women who had not received body-mind therapy (yoga, reiki, meditation, etc.) in the last six months
- Women who agreed to participate to the research
Who cannot join
- Women who could not be contacted for the pre-test application on the 13th postpartum day
- Women who developed a health problem in themselves or/or their newborn
- Women who were diagnosed with a neuro-psychiatric disease
- Women who could not be reached by phone or SMS on the 13th and 14th postpartum days
- Women who wanted to leave the study voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Distant Reiki Therapy on the Postpartum Fatigue and Depression Risk: A Randomized Controlled Trial
This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression.
Read the detailed description
The postpartum period is a process in which the reproductive organs return to their prenatal state during the six weeks after birth, physiological and anatomical changes as well as physical, social and emotional changes occur in the woman, and new roles and responsibilities are learned. Most of the problems seen in this period appear in the first days and continue for periods ranging from six weeks to a year. Risk factors such as hormonal changes seen in the postpartum period in women, having a first baby, stressful life events, insufficient social support and problems in relationships with the spouse cause sleep disruption and fatigue, and therefore can negatively affect the psychological health of the woman.
While many women easily adapt to the physiological, psychological and social changes that occur with pregnancy and birth, psychological problems at various levels occur in women who cannot adapt. One of the psychological problems that develop during this period is postpartum depression. Postpartum depression develops due to biological, psychological and socio-cultural factors, can be seen within the first year after birth, disrupts the health of the mother and the family, and is characterized by symptoms such as sadness, hopelessness, weight changes, chronic fatigue, feelings of worthlessness or guilt, and difficulty in thinking and concentrating. It is a mental illness that is serious and requires treatment. When symptoms of fatigue and depression in the postpartum period are not noticed early and the woman is not provided with the support she needs, this makes it difficult for women to adapt to the postpartum period.
According to the holistic care philosophy, which has an important place in nursing and accepts that the whole is more than the sum of its parts, nurses should handle the individuals they care for with a holistic approach that includes physical health as well as emotional, mental and spiritual well-being. For this reason, in addition to pharmacological methods applied to reduce the fatigue levels of women in the postpartum period and reduce the risk of depression, complementary and alternative therapy methods such as massage, listening to music, acupressure, relaxation exercises and Reiki are also used in nursing research. Reiki, one of these alternative therapy methods, is based on the principle that a blockage or congestion in one of the energy centers such as the head, neck, chest, abdominal cavity and groin causes physical and psychological disorders. Reiki, a Japanese word, means life energy that exists everywhere. Reiki therapy has been defined as a complementary health approach in which the practitioner places his/her hands on or just above a person to direct universal energy to the receiving individual. Reiki, one of the healing methods based on life energy, is increasingly used in nursing studies. In studies conducted in the field of women's health in the literature; It has been determined that Reiki applied to female patients undergoing outpatient surgery before the operation reduces heart rate, systolic blood pressure and anxiety levels and reduces pain and analgesic use after abdominal hysterectomy. In studies conducted on the use of Reiki therapy in the postpartum period, Reiki applied to the post-cesarean intervention group on the first and second post-operative days reduced pain intensity, analgesic need and anxiety level, but had no effect on vital signs, it was found to reduce pain after cesarean section and it was not effective in reducing pain after cesarean section.
Although Reiki therapy has been proven to be effective in coping with many symptoms, studies on its effect on the level of fatigue and depression in the postpartum period are limited. It is predicted that Reiki will reduce the risk of depression by reducing the fatigue of women in the postpartum period and causing spiritual relaxation, due to its advantages such as not being an invasive procedure, ease of application and having no negative effects. For this reason, the research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression.
- Conditions
- PostPartum Depression
- Being tested
- Reiki energy therapy
- Keywords
- Postpartum period, Nursing, Distant Reiki, Postpartum depression, Fatigue
- Medical subject headings
- Depression, Postpartum, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki energy therapyBehavioural
In order to perform distance Reiki application, the practitioner must have completed Reiki II level training according to the Traditional Usui Reiki system and must be attuned by a person with a Usui Reiki Master and Teacher degree. With harmony, the energy channels in the individual's body are opened and the harmonious individual becomes a tool of universal healing energy.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Energy therapy | Experimental | The women in the intervention group were explained how to perform the Reiki application, and the appropriate time for Reiki was planned. Pretest data were obtained by sending the data collection form, VAS-F and EPDS Google form link to women's phones via WhatsApp application.Then, according to Usui Reiki, researchers with Reiki Stage II and Reiki Master \& Teacher degrees applied Reiki to women for 30 minutes consecutively on the 13th, 14th, 20th and 21st postpartum days (in the second and third postpartum weeks). Before each Reiki application, a reminder message was sent to the women informing them that the application would begin, and they were asked to fill out the VAS-F and EPDS again on the 28th day (fourth week) and 56th day (eighth week) postpartum. During this process, women who did not fill out the scale forms were contacted via phone and SMS and were asked to fill out the forms, and those who did not fill out the forms were excluded from the study. Receives: Behavioral: Reiki energy therapy |
| Control | No intervention | No intervention was made to the women in the control group during the research. Women in the control group were asked to fill out the introductory information form and VAS-F and EPDS on the 13th postpartum day, and the VAS-F and EPDS form links were sent to their phones via WhatsApp on the 28th and 56th days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Fatigue (VAS-F)
Lee et al. (1990) and whose Turkish validity and reliability were determined by Yurtsever and Bedük (2003), the scale consists of 18 items. The scale is in the form of a 10 cm ruler with the most positive statements at one end and the most negative statements at the other end. The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10. The most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. The items of the fatigue sub-dimension are from the most positive to the most negative, and the items of the energy sub-dimension are from the most negative to the most positive. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue is high. Evaluation of the scale is done by adding the total scores (0-180) obtained from the items. The scale does not have a cut-off point.
Measured: two months
Edinburgh Postnatal Depression Scale (EPDS)
he scale prepared for screening purposes to determine the risk of depression in the postpartum period was developed by Cox et al. (1987), the scale is not intended to diagnose depression. EPDS consists of 10 items and is a 4-point Likert type. The answers to each question item are scored between 0-3 on a scale consisting of four options, the lowest score that can be obtained from the scale is 0 and the highest score is 30. In the evaluation, the 1st, 2nd, and 4th items are scored as 0, 1, 2, 3, and the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th items are scored reversely as 3, 2, 1. is scored as 0. The total score of the scale is obtained by adding these item scores. The cut-off score of the scale is 12.5 and women whose total scale score is higher than the cut-off point are considered to be in the risk group. Turkish validity and reliability were determined by Aydin et al. (2004) Cronbach Alpha coefficient of the scale was found to be 0.76.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start3 Jun 2022
- Primary completion18 Mar 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostPartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Gökşin, Aksaray University
- Investigators
- ILKNUR GOKSIN, PhD, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364436
- Sponsor's protocol ID
- AksarayU1
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distant Reiki Therapy on the Postpartum Fatigue and Depression Risk: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06364436
- Acronym / sponsor ID
- AksarayU1
- Conditions
- PostPartum Depression
- Keywords
- Postpartum period, Nursing, Distant Reiki, Postpartum depression, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression.
Detailed description
The postpartum period is a process in which the reproductive organs return to their prenatal state during the six weeks after birth, physiological and anatomical changes as well as physical, social and emotional changes occur in the woman, and new roles and responsibilities are learned. Most of the problems seen in this period appear in the first days and continue for periods ranging from six weeks to a year. Risk factors such as hormonal changes seen in the postpartum period in women, having a first baby, stressful life events, insufficient social support and problems in relationships with the spouse cause sleep disruption and fatigue, and therefore can negatively affect the psychological health of the woman.
While many women easily adapt to the physiological, psychological and social changes that occur with pregnancy and birth, psychological problems at various levels occur in women who cannot adapt. One of the psychological problems that develop during this period is postpartum depression. Postpartum depression develops due to biological, psychological and socio-cultural factors, can be seen within the first year after birth, disrupts the health of the mother and the family, and is characterized by symptoms such as sadness, hopelessness, weight changes, chronic fatigue, feelings of worthlessness or guilt, and difficulty in thinking and concentrating. It is a mental illness that is serious and requires treatment. When symptoms of fatigue and depression in the postpartum period are not noticed early and the woman is not provided with the support she needs, this makes it difficult for women to adapt to the postpartum period.
According to the holistic care philosophy, which has an important place in nursing and accepts that the whole is more than the sum of its parts, nurses should handle the individuals they care for with a holistic approach that includes physical health as well as emotional, mental and spiritual well-being. For this reason, in addition to pharmacological methods applied to reduce the fatigue levels of women in the postpartum period and reduce the risk of depression, complementary and alternative therapy methods such as massage, listening to music, acupressure, relaxation exercises and Reiki are also used in nursing research. Reiki, one of these alternative therapy methods, is based on the principle that a blockage or congestion in one of the energy centers such as the head, neck, chest, abdominal cavity and groin causes physical and psychological disorders. Reiki, a Japanese word, means life energy that exists everywhere. Reiki therapy has been defined as a complementary health approach in which the practitioner places his/her hands on or just above a person to direct universal energy to the receiving individual. Reiki, one of the healing methods based on life energy, is increasingly used in nursing studies. In studies conducted in the field of women's health in the literature; It has been determined that Reiki applied to female patients undergoing outpatient surgery before the operation reduces heart rate, systolic blood pressure and anxiety levels and reduces pain and analgesic use after abdominal hysterectomy. In studies conducted on the use of Reiki therapy in the postpartum period, Reiki applied to the post-cesarean intervention group on the first and second post-operative days reduced pain intensity, analgesic need and anxiety level, but had no effect on vital signs, it was found to reduce pain after cesarean section and it was not effective in reducing pain after cesarean section.
Although Reiki therapy has been proven to be effective in coping with many symptoms, studies on its effect on the level of fatigue and depression in the postpartum period are limited. It is predicted that Reiki will reduce the risk of depression by reducing the fatigue of women in the postpartum period and causing spiritual relaxation, due to its advantages such as not being an invasive procedure, ease of application and having no negative effects. For this reason, the research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Energy therapy | Experimental | Behavioral: Reiki energy therapyThe women in the intervention group were explained how to perform the Reiki application, and the appropriate time for Reiki was planned. Pretest data were obtained by sending the data collection form, VAS-F and EPDS Google form link to women's phones via WhatsApp application.Then, according to Usui Reiki, researchers with Reiki Stage II and Reiki Master \& Teacher degrees applied Reiki to women for 30 minutes consecutively on the 13th, 14th, 20th and 21st postpartum days (in the second and third postpartum weeks). Before each Reiki application, a reminder message was sent to the women informing them that the application would begin, and they were asked to fill out the VAS-F and EPDS again on the 28th day (fourth week) and 56th day (eighth week) postpartum. During this process, women who did not fill out the scale forms were contacted via phone and SMS and were asked to fill out the forms, and those who did not fill out the forms were excluded from the study. |
| Control | No intervention | –No intervention was made to the women in the control group during the research. Women in the control group were asked to fill out the introductory information form and VAS-F and EPDS on the 13th postpartum day, and the VAS-F and EPDS form links were sent to their phones via WhatsApp on the 28th and 56th days. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants were 18 years of age or older
- At least a primary school graduate
- Primiparous and multiparous, with a full-term (between 38-40 weeks) and healthy newborn
- Without any acute or chronic health problems, without communication problems that could answer the data collection tools used in the study
- Women who had not received body-mind therapy (yoga, reiki, meditation, etc.) in the last six months
Key exclusion criteria (5 listed)
- Women who could not be contacted for the pre-test application on the 13th postpartum day
- Women who developed a health problem in themselves or/or their newborn
- Women who were diagnosed with a neuro-psychiatric disease
- Women who could not be reached by phone or SMS on the 13th and 14th postpartum days
- Women who wanted to leave the study voluntarily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki energy therapyIn order to perform distance Reiki application, the practitioner must have completed Reiki II level training according to the Traditional Usui Reiki system and must be attuned by a person with a Usui Reiki Master and Teacher degree. With harmony, the energy channels in the individual's body are opened and the harmonious individual becomes a tool of universal healing energy. | Behavioural | Reiki Energy therapy |
Primary outcome
Visual Analog Scale for Fatigue (VAS-F)
Time frame: two months
Lee et al. (1990) and whose Turkish validity and reliability were determined by Yurtsever and Bedük (2003), the scale consists of 18 items. The scale is in the form of a 10 cm ruler with the most positive statements at one end and the most negative statements at the other end. The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10. The most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. The items of the fatigue sub-dimension are from the most positive to the most negative, and the items of the energy sub-dimension are from the most negative to the most positive. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue is high. Evaluation of the scale is done by adding the total scores (0-180) obtained from the items. The scale does not have a cut-off point.
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: two months
he scale prepared for screening purposes to determine the risk of depression in the postpartum period was developed by Cox et al. (1987), the scale is not intended to diagnose depression. EPDS consists of 10 items and is a 4-point Likert type. The answers to each question item are scored between 0-3 on a scale consisting of four options, the lowest score that can be obtained from the scale is 0 and the highest score is 30. In the evaluation, the 1st, 2nd, and 4th items are scored as 0, 1, 2, 3, and the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th items are scored reversely as 3, 2, 1. is scored as 0. The total score of the scale is obtained by adding these item scores. The cut-off score of the scale is 12.5 and women whose total scale score is higher than the cut-off point are considered to be in the risk group. Turkish validity and reliability were determined by Aydin et al. (2004) Cronbach Alpha coefficient of the scale was found to be 0.76.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ILKNUR GOKSIN, PhD principal investigator
Aksaray University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki energy therapy in people with PostPartum Depression, run by Aksaray 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 6 inclusion and 5 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 27 Jun 2024. 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?
Visual Analog Scale for Fatigue (VAS-F) (time frame: two months). The study lists 2 primary outcomes in all. 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 27 Jun 2024.