The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 4, 2022
August 1, 2022
10 months
September 9, 2021
August 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Therapeutic Touch
EXPERIMENTALTD process: * After the procedure was explained, the focus was on the child to be treated, * Intended to help the child's treatment and sleep, * The patient's energy field was scanned with the hands at a distance of 8-12 cm from the patient's skin (2 times) * To remove the blockages determined regarding the energy flow and to facilitate the energy flow, manual cleaning was performed (2 times), * Imbalances in the energy fields were tried to be treated by using mental visualization techniques such as dreaming, positive thinking and visualization, by directing the universal life energy to sick individuals with calm and rhythmic hand movements (2 times), * Reassessed to determine whether success has been achieved in treating imbalances in the energy field.
Music Rest
EXPERIMENTAL* Parents and children will be informed about the "Music Rest" before the procedure. * One day before the "Music Rest" practice, the child's sleep will be evaluated with "Actigraphy". Starting the day after the first measurement, the "Music Rest" will be held for three days as a 20-minute practice period per day. In order to help the child sleep, the child will be listened to music (such as lullaby, classical music) preferred by the patient or his family. * Before the "Music Rest" application, the patient's room will be ventilated and a spacious and quiet environment will be provided during the application. * The sound level of the music played will be kept between 45-65 dB. * Nursing interventions will be written in more detail after the data of the research is collected.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Being within a period of at least one month and at most two years after the transplant
- years old
- Conscious
- spontaneous breathing
- No hearing problems
- Pain free
- Children who do not use sleeping pills will be included in the study.
You may not qualify if:
- Children with pain
- Children using sleeping pills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maksude YILDIRIMlead
- Inonu Universitycollaborator
Study Sites (1)
Inönü University
Malatya, Battalgazi, 44280, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emriye Hilal YAYAN, PhD
Inönü University
- PRINCIPAL INVESTIGATOR
Maksude YILDIRIM, Msc
Inönü University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
September 9, 2021
First Posted
November 5, 2021
Study Start
February 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 4, 2022
Record last verified: 2022-08