Clinical trial NCT05108636: The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation
Official title: The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant Disorder
Sleep
Keywords: Liver
Transplant
Therapeutic touch
Music
Sleep
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2021-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Today, the demand for liver transplantation is increasing day by day, since liver transplantation is considered the most effective treatment for end-stage liver disease. Patients who have undergone major surgery such as liver transplantation may experience sleep-related problems due to common complications of surgical procedures. However, in some studies, it is stated that practices such as acupuncture, exercise, mindfulness, therapeutic touch, listening to music, yoga, etc., performed by nurses, reduce the sleep-related problems of patients. In this study, the effects of therapeutic touch and music on the sleep of children with liver transplantation will be examined.

Detailed description: Liver transplantation is considered the most effective method in the treatment of end-stage liver disease. For this reason, the number of patients waiting and receiving liver transplantation is increasing day by day. While the total number of adult and pediatric patients awaiting liver transplantation in our country in 2018 was 2142, the number of patients who received transplantation was 1587, the number of patients awaiting liver transplantation in 2019 was 2261, and the number of patients with transplantation was 1776.

Patients undergoing major surgery, frequently encountered conditions such as pain caused by surgical procedures, noise in surgical clinics, stress due to surgical procedure, they may experience sleep-related problems due to concerns arising from uncertainties about the process. Rabbits et al. reported in their study that poor sleep quality associated with postoperative pain is common in children undergoing major surgery. In some studies with children who have been transferred, it has been determined that children have complaints such as irregular breathing during sleep, excessive daytime sleepiness, daytime behavior problems and restless legs. Petersen et al. determined that fatigue was seen in the majority of children with liver transplantation and this fatigue was mostly associated with sleep/rest.

Sleep is a very important process for maintaining a healthy life and human health is significantly affected in cases of insomnia or poor sleep quality. While the catabolic process is active during wakefulness, the anabolic process is activated during sleep. Considering the anabolic process during sleep, it is of great importance for patients to have a quality sleep, especially after surgical intervention, in order to regain their old health. However, studies show that major surgical interventions cause deterioration in sleep quality. With good nursing care after the surgical procedure, patients can have a quality sleep. In some studies, it is stated that complementary and alternative treatment methods such as acupuncture, exercise, mindfulness, therapeutic touch, listening to music, yoga affect sleep positively. One of these complementary and alternative treatment methods is therapeutic touch. Therapeutic touch (TD) is based on the assumption that humans have energy fields and that these energy fields interact with the environment. In addition, therapeutic touch advocates the idea that there are imbalances in the energy fields of the sick individuals and that these imbalances can be corrected with the application of TD and contribute to the healing process. Efendi et al., in their study with preterm infants, determined that therapeutic touch and listening to the mother's voice increase the sleep quality of preterm infants. Hedlund et al., in their study with children with fontan (single ventricle) circulation, determined that exercise increased sleep quality. When the literature was examined, only one study was found to improve the sleep quality of children who had undergone surgery. In addition, no study has been found in the literature examining the effect of therapeutic touch on the sleep of children with liver transplantation. In this study, the effects of therapeutic touch and music on the sleep of children with liver transplantation will be examined.

Eligibility criteria: Inclusion Criteria:

* Being within a period of at least one month and at most two years after the transplant
* 0-18 years old
* Conscious
* spontaneous breathing
* No hearing problems
* Pain free
* Children who do not use sleeping pills will be included in the study.

Exclusion Criteria:

* Children with pain
* Children using sleeping pills

Primary outcomes:
measure: The effect of therapeutic touch on sleep
timeFrame: 10 months
measure: The effect of music on sleep
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inönü University
state: Battalgazi
Study officials:
affiliation: Inönü University
name: Emriye Hilal YAYAN, PhD
role: STUDY_DIRECTOR
affiliation: Inönü University
name: Maksude YILDIRIM, Msc
role: PRINCIPAL_INVESTIGATOR
References: