The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation

Sleep Clinical Trial

Official title:

The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108636
• Other study ID #: TDK-2020-2358
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Disorder
• Sleep

Intervention

Other:
• Therapeutic Touch
Therapeutic touch; It is a low-cost, non-contra-indications, easy-to-apply and non-invasive form of complementary therapy that can be applied anywhere and at any time (Vanaki et al., 2016). Therapeutic touch was developed by Krieger in 1975 as a nursing intervention to help and even heal the patient by balancing the patient's energy field (Marta et al., 2010). The basic assumption of therapeutic touch is that people have energy fields and these energy fields interact with the environment (Hanley, 2008). Therapeutic touch aims to harmonize, renew and heal the flow of the human energy field by removing the blockages of a person's biofield (Mueller et al., 2019). Unlike other touch-based methods such as massage therapy, therapeutic touch does not require the practitioner to physically touch the patient. Instead, the practitioner uses their hands to focus their energy and intent to help the recipient (Hanley, 2008).
• Music Rest
The use of music in the treatment of diseases has been seen in many civilizations since ancient times. In ancient Greek and Roman communities, individuals resorted to music to get rid of their humanitarian problems, while in Ancient Egypt, music was used to give strength to patients during birth (Kor & Adar, 2016). In today's studies, it has been determined that music positively affects the physiological parameters, nutrition, hospital stay and sleep of the patients (O'Toole et al., 2017; Van Der Heijden et al., 2016). It is important that the sound level is within the appropriate limits while listening to music to the patients. The American Academy of Pediatrics recommends a sound level between 45dB- a maximum of 65dB (ACOG - AAP, 2012). The World Health Organization recommends a sound level of 35 dB during the day and 30 dB at night (Berglund et al., 2000).

Locations

Country	Name	City	State
Turkey	Inönü University	Malatya	Battalgazi

Sponsors (2)

Lead Sponsor	Collaborator
Maksude YILDIRIM	Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of therapeutic touch on sleep	The actigraphy device, which can be easily attached to the wrist of the patients, is used to evaluate and document the physical movements of the patients related to sleep. The device can keep a record of the patient's activity for 24 hours. The patient's information can be read and evaluated with the help of a special software of the device.; After measuring the sleep of the patients with the actigraphy device for 24 hours, therapeutic touch will be applied for 3 days and at the end of the 3rd day, their sleep will be measured again with the actigraphy device for 24 hours.	10 months
Primary	The effect of music on sleep	The actigraphy device, which can be easily attached to the wrist of the patients, is used to evaluate and document the physical movements of the patients related to sleep. The device can keep a record of the patient's activity for 24 hours. The patient's information can be read and evaluated with the help of a special software of the device.; After the patients' sleep is measured with an actigraphy device for 24 hours, they will listen to music they want for 3 days, and at the end of the 3rd day, their sleep will be measured again with an actigraphy device for 24 hours.	10 months