NCT05108636

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

September 9, 2021

Last Update Submit

August 3, 2022

Conditions

Keywords

LiverTransplantTherapeutic touchMusicSleep

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

EXPERIMENTAL

TD 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.

Other: Therapeutic Touch

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.

Other: Music Rest

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).

Therapeutic Touch

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).

Music Rest

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Inönü University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Emriye Hilal YAYAN, PhD

    Inönü University

    STUDY DIRECTOR
  • Maksude YILDIRIM, Msc

    Inönü University

    PRINCIPAL INVESTIGATOR

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

Locations