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Not yet recruiting NCT07728266

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

No phase Interventional Circumcision

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic Touch, Music intervention.
Who it may be relevant to
Registry conditions: Circumcision. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Therapeutic Touch and Music on Anxiety, Pain, and Nausea in Children Before and After Circumcision: A Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral Therapeutic Touch
    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.
  • Behavioral Music intervention
    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.

Primary outcome measures

  • Pain Intensity [Time frame: 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 [Time frame: 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 [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07728266 · OABI_IGDIR_02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗