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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duygu Demir, PhD | University of Yalova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Yalova | Yalova | Yalova | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23203652 | Background | 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. | |
| 12811319 | 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. |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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.
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The research consists of 2 groups. These groups are Reiki group, control group.
| 15068660 | 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. |
| 27058159 | Result | 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. |
| 21998438 | 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. |
| 31794639 | 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. |
| 32150292 | 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. |
| 29676928 | 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. |
| 27453882 | 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. |
| 26858170 | 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. |