Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
44 participants
INTERVENTIONAL
2025-07-01
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Colic Massage and Kangaroo Care on Babies and Their Mothers
NCT06727760
The Effect of Aromatherapy Application on Pain, Stress and Behaviors of the Newborn
NCT05770999
The Effect of Reiki on the Anxiety Level of Mothers
NCT06487182
The Effect of Spa and Massage on Babies on Colic Symptoms
NCT05538936
The Effect of Affirmation and Massage on Babies
NCT05489861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study was designed as a double-blind, randomized controlled experimental study with a pretest-posttest design to determine the effect of Reiki therapy administered to infants with infantile colic on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
To ensure homogeneous distribution of the groups, randomization was performed using a computer-based program (http://www.randomization.com
, balanced permutation method). Infants who met the inclusion criteria and whose families agreed to participate were randomly assigned to either the experimental (Reiki) group or the control group according to the randomization list.
The control variables of the study were the infants' demographic characteristics, while the dependent variables were colic pain, crying duration, maternal fatigue level, and maternal quality of life scores.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Reiki Group
Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting 20-30 minutes, administered by a certified Reiki practitioner following a standardized protocol.
Reiki
Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting 20-30 minutes, administered by a certified Reiki practitioner following a standardized protocol.
Control Group
Infants in the control group will receive only routine pediatric care and will not receive any Reiki therapy or additional intervention.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Reiki
Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting 20-30 minutes, administered by a certified Reiki practitioner following a standardized protocol.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
3 Weeks
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Yalova
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Duygu Demir
PhD, RN
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Duygu Demir, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Yalova
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Yalova
Yalova, Yalova, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Den Oudsten BL, Zijlstra WP, De Vries J. The minimal clinical important difference in the World Health Organization Quality of Life instrument--100. Support Care Cancer. 2013 May;21(5):1295-301. doi: 10.1007/s00520-012-1664-8. Epub 2012 Dec 1.
Cirgin Ellett ML, Murphy D, Stroud L, Shelton RA, Sullivan A, Ellett SG, Ellett LD. Development and psychometric testing of the infant colic scale. Gastroenterol Nurs. 2003 May-Jun;26(3):96-103. doi: 10.1097/00001610-200305000-00002.
Pavliuk-Pavliuchenko LL. [An osteotome for the nose]. Stomatologiia (Mosk). 1992 May-Dec;(3-6):84-5. No abstract available. Russian.
Charkhandeh M, Talib MA, Hunt CJ. The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents. Psychiatry Res. 2016 May 30;239:325-30. doi: 10.1016/j.psychres.2016.03.044. Epub 2016 Mar 30.
Birocco N, Guillame C, Storto S, Ritorto G, Catino C, Gir N, Balestra L, Tealdi G, Orecchia C, Vito GD, Giaretto L, Donadio M, Bertetto O, Schena M, Ciuffreda L. The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Am J Hosp Palliat Care. 2012 Jun;29(4):290-4. doi: 10.1177/1049909111420859. Epub 2011 Oct 13.
Wein P, Handler M, Chadda KD. Severe thrombocytopenia as a result of contrast left ventricular angiography. Cathet Cardiovasc Diagn. 1982;8(5):495-9. doi: 10.1002/ccd.1810080511.
Hjern A, Lindblom K, Reuter A, Silfverdal SA. A systematic review of prevention and treatment of infantile colic. Acta Paediatr. 2020 Sep;109(9):1733-1744. doi: 10.1111/apa.15247. Epub 2020 Jun 2.
Icke S, Genc R. Effect of Reflexology on Infantile Colic. J Altern Complement Med. 2018 Jun;24(6):584-588. doi: 10.1089/acm.2017.0315. Epub 2018 Apr 20.
Lecuire J, Dechaume JP, Buffard P, Bochu M. [Meningiomas of the posterior cranial fossa]. Neurochirurgie. 1971 May;17:1-146. No abstract available. French.
Thrane SE, Maurer SH, Ren D, Danford CA, Cohen SM. Reiki Therapy for Symptom Management in Children Receiving Palliative Care: A Pilot Study. Am J Hosp Palliat Care. 2017 May;34(4):373-379. doi: 10.1177/1049909116630973. Epub 2016 Feb 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
duygudemir Colic
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.