The Effects of Reiki Therapy in Infants With Colic

NCT07254520 | Recruiting

• 1 other identifier: duygudemir Colic
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reiki; Colic, Infantile

Keywords

Reiki Therapy; Infantile colic; Maternal fatigue; Infant crying; Quality of life

Outcome Measures

Primary Outcomes (4)

• Change in Infantile Colic Symptom Score

  Measured using the Infantile Colic Scale completed by the mother.

  At baseline and 7th day

• Crying Duration of Infants with Infantile Colic

  The mother records the start and end time of each crying episode over a 24-hour period for seven consecutive days to determine the total daily crying duration.

  Recorded by the mother over a 7-day period (24 hours per day).

• Change in Maternal Fatigue Level

  Maternal fatigue is assessed using the Visual Analogue Scale for Fatigue (VAS-F), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal fatigue level.

  At baseline and 7th day

• Change in Maternal Quality of Life

  Maternal quality of life is assessed using the World Health Organization Quality of Life Assessment (WHOQOL), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal quality of life

  At baseline and 7th day

Study Arms (2)

Reiki Group

EXPERIMENTAL

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.

Other: Reiki

Control Group

NO INTERVENTION

Infants in the control group will receive only routine pediatric care and will not receive any Reiki therapy or additional intervention.

Interventions

Reiki OTHER

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 Group

Eligibility Criteria

• Age: 3 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

University of Yalova

Yalova, Yalova, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 23203652 BACKGROUND

• 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.

  PMID: 12811319 BACKGROUND

• Gay CL, Lee KA, Lee SY. Sleep patterns and fatigue in new mothers and fathers. Biol Res Nurs. 2004 Apr;5(4):311-8. doi: 10.1177/1099800403262142.

  PMID: 15068660 BACKGROUND

• 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.

  PMID: 27058159 RESULT

• 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.

  PMID: 21998438 RESULT

• Gordon M, Gohil J, Banks SS. Parent training programmes for managing infantile colic. Cochrane Database Syst Rev. 2019 Dec 3;12(12):CD012459. doi: 10.1002/14651858.CD012459.pub2.

  PMID: 31794639 RESULT

• 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.

  PMID: 32150292 RESULT

• 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.

  PMID: 29676928 RESULT

• Sheidaei A, Abadi A, Zayeri F, Nahidi F, Gazerani N, Mansouri A. The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial. Med J Islam Repub Iran. 2016 Apr 9;30:351. eCollection 2016.

  PMID: 27453882 RESULT

• 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.

  PMID: 26858170 RESULT

MeSH Terms

Conditions

Colic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Duygu Demir, PhD

  University of Yalova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Demir, PhD

CONTACT

05053662358; duygu.demir@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research consists of 2 groups. These groups are Reiki group, control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Model Details: The study are conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine. The research consists of 2 groups. These groups are Reiki group, control group.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)