The Effect of Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis Treatment: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
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.
详细描述
The study is a randomized controlled, non-blinded, experimental trial. 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. In order to prevent bias and increase the validity of the data, the pain scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:45), their parents as the people who know the children best (n:45), and a researcher specialized in pediatric nursing (n:1), and the inter-observer agreement was examined.
The data collection phase of the research is planned to be completed between June 2025-2026.In this experimental study, the children and their parents who came to the nephrology clinics were evaluated in terms of the inclusion criteria and the children and parents who did not meet the criteria were excluded from the study. The children and parents complying with the inclusion criteria were informed about the study and their written and verbal consents were received. Pre-application will be made before starting the data collection process.
Pilot Study Phase: Children and parents meeting the inclusion criteria will be informed about the study and their verbal and written consent will be obtained. A pilot will be conducted with five children. Based on the results, data collection tools will be revised if necessary.
Pre-Implementation Phase: Children and parents included in the sample will be informed about the study. Written and verbal consent will be obtained. The "Descriptive Information Form" and "Vital Signs Evaluation Form" will be completed by the researcher before the peritoneal dialysis session begins. To avoid causing additional pain, no invasive procedure will be performed within 30 minutes prior to the PD session. Group assignments will be determined through randomization. The PD session will be performed in accordance with physician recommendations.
Implementation Phase: To eliminate variation from different nursing techniques, data collection and application of non-pharmacological interventions will be carried out solely by the researcher. Each child will participate in the control, aromatherapy, and music therapy groups in a randomized order (n = 45 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Decline to participate in the study,
- •Peritonitis diagnosis,
- •Pain due to catheter immobilization,
- •Receiving the first session of peritoneal dialysis treatment
研究组 & 干预措施
Aromatherapy
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.
干预措施: Aromatherapy (Procedure)
Music Therapy
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.
干预措施: Music Therapy (Procedure)
Control
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.
干预措施: Control (Procedure)
结局指标
主要结局
Pain severity
时间窗: 12 months
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.
次要结局
- Heart Rate Monitoring(12 months)
- Oxygen Saturation Monitoring(12 months)
- Parental Satisfaction(12 months)
研究者
Eda Aktaş
PhD, RN, Associate Professor
Istanbul Saglik Bilimleri University