Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis

NCT07040410 | Not Yet Recruiting DMC

• 1 other identifier: KAEK-11/30.04.2025.142
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an experimental randomized controlled study conducted to compare the effect of two different nonpharmacological treatment methods (aromatherapy and music therapy) on pain, vital signs and parental satisfaction to alleviate or eliminate pain during excretion and filling in children undergoing peritoneal dialysis treatment. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025- 2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. This method is suitable for studies with a small sample size. Since three different interventions will be applied once per session over three sessions, to avoid bias, the order of interventions will be randomized and labeled as A, B, and C. The researcher will write the names of the interventions on three separate papers, draw them one by one, and assign them accordingly: Method A: Aromatherapy, Method B: Music Therapy, Method C: Control. Then, the six possible sequences (ABC, ACB, BAC, BCA, CAB, CBA) will be written on six papers and drawn randomly to determine the intervention order for each participant.

Conditions

Pain; Vital Signs Monitoring; Parental Satisfaction

Keywords

peritoneal dialysis treatment; pain management; pain in children; non-pharmacological method; satisfaction

Outcome Measures

Primary Outcomes (1)

• Pain severity

  The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales. The scale will be applied at 0 and 1 minute of the first outflow and inflow phases by the researcher.

  12 months

Secondary Outcomes (3)

• Heart Rate Monitoring

  12 months

• Oxygen Saturation Monitoring

  12 months

• Parental Satisfaction

  12 months

Study Arms (3)

Aromatherapy

EXPERIMENTAL

Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group.

Procedure: Aromatherapy

Music Therapy

EXPERIMENTAL

Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.

Procedure: Music Therapy

Control

EXPERIMENTAL

Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.

Procedure: Control

Interventions

Aromatherapy PROCEDURE

Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil

Aromatherapy

Music Therapy PROCEDURE

Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.

Music Therapy

Control PROCEDURE

Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.

Control

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children will be included between the ages of 3 and 18 who receive instrumental peritoneal dialysis or continuous outpatient peritoneal dialysis treatment.
• Children who have a sufficient cognitive level (3-18 years) to determine pain scores,
• Children who have a healthy hearing and vision system,
• Children who did not take painkillers, opioids or sedatives 6 hours before the study,
• Children who have absence of severe pain in another part of the body,
• Children who have absence of a history of allergies,
• Children and parents who can speak and understand Turkish.

You may not qualify if:

• Decline to participate in the study,
• Peritonitis diagnosis,
• Pain due to catheter immobilization,
• Receiving the first session of peritoneal dialysis treatment

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

İstanbul Sağlık Bilimleri University

Istanbul, Üsküdar, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia; Personal Satisfaction

Interventions

Aromatherapy; Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Eda Aktaş, PhD, RN, Associate Professor

CONTACT

+90 530 558 90 36; eda.aktas@sbu.edu.tr

Burcu Aykanat Girgin, PhD, RN, Associate Professor

CONTACT

+90 537 920 06 83; burcuaykanat.girgin@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Associate Professor

Model Details: This study is designed as an interventional, cross-over, randomized-controlled design.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: The third and fourth researchers will share data with the first and second researchers online during the data collection and analysis phases.

Locations

TU (1)