Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision

NCT07728266 | Not Yet Recruiting

• 1 other identifier: OABI_IGDIR_02
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effects of therapeutic touch and music therapy on anxiety, pain, and nausea in children undergoing circumcision surgery. Circumcision is a common surgical procedure, and children often experience significant anxiety, pain, and nausea both before and after the operation. The study involves children aged 7 to 12 years old who are scheduled for circumcision at Iğdır State Hospital. Participants will be randomly assigned to one of three groups: a therapeutic touch group, a music therapy group, or a control group. The goal of this research is to determine if applying non-pharmacological methods-specifically therapeutic touch or listening to music-for 15 minutes before and after the surgery can effectively reduce children's anxiety, pain levels, and nausea compared to standard care.

Conditions

Circumcision

Keywords

Circumcision; Therapeutic Touch; Music Therapy

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Pain intensity will be evaluated using the Wong-Baker FACES Pain Rating Scale. This assessment tool uses a scoring system ranging from 0 to 5, where 0 represents "no pain" and 5 represents "very severe pain," correlating with the patient's chosen facial expression.

  Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.

• Nausea Severity

  Nausea will be assessed using the Baxter Retching Faces (BARF) Nausea Scale. This pictorial scale consists of six faces and is scored from 0 to 10, where 0 indicates no nausea/vomiting and 10 indicates severe nausea/vomiting.

  Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op

• Anxiety Level

  The children's state anxiety will be measured using the Children's Anxiety Scale-State (CAS-S) / Çocuk Anksiyete Skalası-Durumluluk (ÇAS-D). This is a visual analog scale shaped like a thermometer with a bulb at the bottom and horizontal lines increasing upwards, specifically designed for children aged 4 to 12. Children are instructed to indicate their level of worry or tension by drawing a line on the thermometer. Before administering the scale, the child's ability to understand instructions and sequence numbers (such as counting to 10 or determining if 7 or 4 is larger) is evaluated; children who cannot complete these cognitive tasks do not complete the scale. The total score ranges from 0 to 10, with higher scores representing higher levels of anxiety.

  Four specific time points: (1) Baseline before any intervention is applied, (2) 15 minutes after the pre-operative intervention, (3) 60 minutes post-operation after sedation has worn off and the child is conscious, and (4) 15 minutes after the post-op.

Study Arms (3)

Experimental: Therapeutic Touch Group

EXPERIMENTAL

Participants in this group will receive a 15-minute therapeutic touch intervention prior to the circumcision surgery. Post-operatively, 60 minutes after the operation when the effects of sedation have passed and the child has regained consciousness, they will receive another 15-minute therapeutic touch intervention.

Behavioral: Therapeutic Touch

Experimental: Music Group

EXPERIMENTAL

Participants in this group will listen to music for 15 minutes before the circumcision surgery. Post-operatively, 60 minutes after the operation once sedation effects have worn off, they will listen to music for an additional 15 minutes.

Behavioral: Music intervention

No Intervention: Control Group

NO INTERVENTION

Participants in this group will receive only the standard routine hospital care for their procedure. No additional experimental interventions (neither therapeutic touch nor music) will be applied to this group.

Interventions

Therapeutic Touch BEHAVIORAL

A certified researcher will apply therapeutic touch to the child for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), another 15-minute therapeutic touch session will be applied.

Experimental: Therapeutic Touch Group

Music intervention BEHAVIORAL

The child will listen to music for 15 minutes before the circumcision operation. Following the surgery (approximately 60 minutes later, once the effects of sedation have passed and the child is conscious), the child will listen to music for an additional 15 minutes.

Experimental: Music Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 7 and 12 years
• Children and parents who provide written and verbal informed consent
• Children without any chronic diseases
• Children and parents without visual impairments

You may not qualify if:

• Children and parents who refuse to participate or do not volunteer for the study (do not sign the consent form)
• Participants who display behaviors incompatible with the research content -Participants who subsequently refuse to participate in the research after initial consent
• Participants with incomplete data

Sponsors & Collaborators

• Igdir University: lead

Related Publications (1)

• Sharara-Chami R, El-Hout Y, Lakissian Z, Hafez B, Abi-Gerges C, Fayad J, Charafeddine L, Tazian V, Tamim H, Zaghal A. Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial. J Pediatr Urol. 2022 Apr;18(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2021.12.011. Epub 2021 Dec 24.

  PMID: 35000838 BACKGROUND

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Özlem abı

CONTACT

+905538840573; ozlemabi89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: The study is designed as a randomized controlled trial where participants are concurrently assigned to one of three separate groups: a therapeutic touch group, a music group, and a standard care control group

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 12, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share