Obstetric ComplicationNCT05942989
The Effect of Reiki on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life
A study testing Reiki implementation in people with Obstetric Complication, run by Cukurova University.
Trial summary
Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Complication
- What is being tested?
- Reiki implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Aug 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First pregnancy In 28th and above gestational week Able to read and write Open to communication
Who cannot join
- Having psychiatric history Diagnosed with risky pregnancy Having congenital anomaly in the baby in the postpartum period Having the childbirth preparation classes Receiving energy therapies before and having reiki training certificate
About this study
Official title: The Effect of Reiki Applied to Pregnant Women in the Last Trimester on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life: A Randomized Controlled Study
Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.
Read the detailed description
Reiki, one of the complementary and alternative therapy (CAM) methods; It means "universal life energy" and is natural healing energy (Müller \& Günther, 2006). This healing method is a way of treating others physically and spiritually (Vitale\&O'Connor, 2006; Yücel, 2007). Reiki focuses on energy chakras and bio-psycho-spiritual healing. Reiki enables vital signs (blood pressure, pulse rate, respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep, reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces the use of painkillers and increases coping skills. (Anderson \& Ameling, 2001; Kelley \& William, 2009; Lee et al., 2003; Pocotte \& Salvador, 2008; Vitale, 2006).
Nurses are responsible for increasing the general health level of the mother by detecting and treating the existing diseases in the pregnant, providing timely diagnosis and treatment of potential problems that may arise, monitoring and evaluating the development of the mother and the fetus during pregnancy, giving care to the mother during pregnancy, general body care, nutrition, activity, family planning, It is responsible for providing information on signs of danger, care of the newborn and other issues that the mother may need, preparing the mother for birth physiologically and psychologically, thus increasing the quality of life of the mother (Taşkın, 2016).
- Conditions
- Obstetric Complication
- Being tested
- Reiki implementation
- Keywords
- reiki, breastfeeding, self-efficiency, quality of life
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki implementationOther
Reiki is implied by putting hands on the patient and it is believed that energy is transferred to patients by hands.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group that given education | Experimental | Reiki group Receives: Other: Reiki implementation |
| Control group | No intervention | Group with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of reiki
Reiki may affect breastfeeding self-efficacy and compliments in pregnancy
Measured: starting from 28th gestational week until postpartum 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Keklik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942989
- Sponsor's protocol ID
- 134
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki Applied to Pregnant Women in the Last Trimester on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05942989
- Acronym / sponsor ID
- 134
- Conditions
- Obstetric Complication
- Keywords
- reiki, breastfeeding, self-efficiency, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 12 Jul 2023 (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.
Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.
Detailed description
Reiki, one of the complementary and alternative therapy (CAM) methods; It means "universal life energy" and is natural healing energy (Müller \& Günther, 2006). This healing method is a way of treating others physically and spiritually (Vitale\&O'Connor, 2006; Yücel, 2007). Reiki focuses on energy chakras and bio-psycho-spiritual healing. Reiki enables vital signs (blood pressure, pulse rate, respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep, reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces the use of painkillers and increases coping skills. (Anderson \& Ameling, 2001; Kelley \& William, 2009; Lee et al., 2003; Pocotte \& Salvador, 2008; Vitale, 2006).
Nurses are responsible for increasing the general health level of the mother by detecting and treating the existing diseases in the pregnant, providing timely diagnosis and treatment of potential problems that may arise, monitoring and evaluating the development of the mother and the fetus during pregnancy, giving care to the mother during pregnancy, general body care, nutrition, activity, family planning, It is responsible for providing information on signs of danger, care of the newborn and other issues that the mother may need, preparing the mother for birth physiologically and psychologically, thus increasing the quality of life of the mother (Taşkın, 2016).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group that given education | Experimental | Other: Reiki implementationReiki group |
| Control group | No intervention | –Group with no intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- First pregnancy In 28th and above gestational week Able to read and write Open to communication
Key exclusion criteria (1 listed)
- Having psychiatric history Diagnosed with risky pregnancy Having congenital anomaly in the baby in the postpartum period Having the childbirth preparation classes Receiving energy therapies before and having reiki training certificate
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 implementationReiki is implied by putting hands on the patient and it is believed that energy is transferred to patients by hands. | Other | Intervention group that given education |
Primary outcome
Effect of reiki
Time frame: starting from 28th gestational week until postpartum 6th week
Reiki may affect breastfeeding self-efficacy and compliments in pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki implementation in people with Obstetric Complication, run by Cukurova University.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Effect of reiki (time frame: starting from 28th gestational week until postpartum 6th week). 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 12 Jul 2023.