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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorIstanbul Saglik Bilimleri University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Decline to participate in the study,

Peritonitis diagnosis,

Pain due to catheter immobilization,

Receiving the first session of peritoneal dialysis treatment

Trial design

Design model

Crossover

Treatments tested in this trial

  • Aromatherapy

    Procedure/Surgery

    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

  • Music Therapy

    Procedure/Surgery

    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.

  • Control

    Procedure/Surgery

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: AromatherapyExperimental treatment 1 intervention
Group B: Music TherapyExperimental treatment 1 intervention
Group C: ControlExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Heart Rate Monitoring

Developed by the researchers, this form records heart rate using a Philips monitor before, during (0 and 1 minute), and after the first outflow and inflow.

Time frame
12 months
2

Oxygen Saturation Monitoring

Developed by the researchers, this form records oxygen saturation using a Philips monitor before, during (0 and 1 minute), and after the first outflow and inflow.

Time frame
12 months
3

Parental Satisfaction

This researcher-developed questionnaire evaluates parent satisfaction with the non-pharmacological pain management method applied during the first inflow and outflow of PD. It consists of five yes/no questions. Each "yes" is scored as 1 and each "no" as 0, with total scores ranging from 0 to 10. Higher scores indicate greater satisfaction. The form will be completed after the first PD session

Time frame
12 months

Other outcomes

Sponsors and contacts

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