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CompletedNCT07254520Updated May 29, 2026

The Effects of Reiki Therapy in Infants With Colic

An interventional study of Reiki in Reiki and Colic, Infantile, sponsored by University of Yalova. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Weeks to 6 Months. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jul 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
3 Weeks to 6 Months
Sex
All
01

Study 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.

Read the detailed description

The study population consisted of infants aged 3 weeks to 6 months who were diagnosed with infantile colic and met the inclusion criteria, presenting to pediatric health and disease outpatient clinics.

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.

02

Conditions studied

  • Reiki
  • Colic, Infantile

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Keywords

  • Reiki Therapy
  • Infantile colic
  • Maternal fatigue
  • Infant crying
  • Quality of life
03

In context

Colic

127 studies on the registry are indexed under Colic; 18 are open to participants now.

This study's enrollment of 44 is below the median of 76 across 110 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

University of Yalova is the lead sponsor of 61 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Weeks to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    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.

    Other: Reiki

  • No intervention
    Control Group

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

Interventions

  • OtherReiki

    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.

06

What researchers measure

Primary outcomes

  1. Change in Infantile Colic Symptom Score

    Measured using the Infantile Colic Scale completed by the mother.

    Time frame: At baseline and 7th day

  2. 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.

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

  3. 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.

    Time frame: At baseline and 7th day

  4. 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

    Time frame: At baseline and 7th day

07

Study locations

1 site
  • University of Yalova
    Yalova, Yalova, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 23203652 ↗
  • 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. PubMed 12811319 ↗
  • 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. PubMed 15068660 ↗
  • 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. PubMed 27058159 ↗
  • 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. PubMed 21998438 ↗
  • 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. PubMed 31794639 ↗
  • 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. PubMed 32150292 ↗
  • 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. PubMed 29676928 ↗
  • 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. PubMed 27453882 ↗
  • 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. PubMed 26858170 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07254520
Lead sponsor
University of Yalova
Responsible party
Duygu Demir (PhD, RN, University of Yalova) — Principal investigator
First posted
Nov 28, 2025
Start date
Jul 1, 2024
Primary completion
Jun 1, 2025
Completion
Jul 1, 2025
Last update
May 29, 2026

Study contacts

Duygu Demir, PhD
principal investigator · University of Yalova

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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