The Effects of Reiki Therapy in Infants With Colic (NCT07254520) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Reiki Therapy in Infants With Colic
Turkey (Türkiye)44 participantsStarted 2024-07-01
Plain-language summary
This double-blind, randomized controlled experimental study aims to determine the effect of Reiki therapy administered to infants with infantile colic (aged 3 weeks to 6 months) on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
The study population consists of infants aged 3 weeks to 6 months who are diagnosed with infantile colic and present to pediatric health and disease outpatient clinics between July 2025 and July 2026. A total of 44 infants meeting the inclusion criteria will be randomly assigned to either the Reiki group (n = 22) or the control group (n = 22).
Data will be collected using the Mother and Infant Descriptive Information Form, the Infantile Colic Scale, the Crying Duration Recording Form, the Visual Analogue Scale for Fatigue (for mothers), and the World Health Organization Quality of Life Scale (WHOQOL) (for mothers).
Reiki therapy will be administered to the intervention group twice on alternate days for 20-30 minutes per session. The control group will not receive any intervention.
Who can participate
Age range
3 Weeks – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants aged between 3 weeks and 6 months.
* Diagnosed with infantile colic by a physician during the study period.
* Birth weight between 2500 and 4000 grams.
* No presence of any chronic disease in the infant.
* Family voluntarily agrees to participate in the study.
* Mother has no visual or hearing impairments.
* Mother is open to communication and cooperation.
* Mother is able to read and understand Turkish.
* Neither the mother nor the infant has received any form of energy therapy (e.g., yoga, Reiki, massage, meditation, or healing touch) within the last five months.
Exclusion Criteria:
* Infants with any acute or chronic illness.
* Infants with congenital anomalies.
* Mothers with diagnosed psychological or mental health disorders.
* Infants diagnosed with lactose intolerance by a physician.
* Infants who have previously been diagnosed with infantile colic and are continuing medical treatment for this condition.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Infantile Colic Symptom Score
Timeframe: At baseline and 7th day
2
Crying Duration of Infants with Infantile Colic
Timeframe: Recorded by the mother over a 7-day period (24 hours per day).