Liver Transplant DisorderNCT05108636
The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation
A study testing Therapeutic Touch and Music Rest in people with Liver Transplant Disorder and Sleep, run by Maksude YILDIRIM at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Liver Transplant Disorder, Sleep
- What is being tested?
- Therapeutic Touch and Music Rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children with pain
- Children using sleeping pills
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Liver Transplant Disorder, Sleep
- Being tested
- Therapeutic Touch, Music Rest
- Keywords
- Liver, Transplant, Therapeutic touch, Music, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
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 RestOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maksude YILDIRIM
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Maksude YILDIRIM, Inonu University
- Investigators
- Emriye Hilal YAYAN, PhD, Study director, Inönü UniversityMaksude YILDIRIM, Msc, Principal investigator, Inönü University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108636
- Sponsor's protocol ID
- TDK-2020-2358
- Status last verified
- Aug 2022
- First submitted
- 9 Sep 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation
- ClinicalTrials.gov ID
- NCT05108636
- Acronym / sponsor ID
- TDK-2020-2358
- Conditions
- Liver Transplant Disorder, Sleep
- Keywords
- Liver, Transplant, Therapeutic touch, Music, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maksude YILDIRIMUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch | Experimental | Other: Therapeutic TouchTD 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 | Other: Music Rest* 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Children with pain
- Children using sleeping pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchTherapeutic 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). | Other | Therapeutic Touch |
| Music RestThe 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). | Other | Music Rest |
Primary outcome
The effect of therapeutic touch on sleep
Time frame: 10 months
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.
The effect of music on sleep
Time frame: 10 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Related trials for Liver Transplant Disorder
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emriye Hilal YAYAN, PhD study director
Inönü University
Maksude YILDIRIM, Msc principal investigator
Inönü University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch and Music Rest in people with Liver Transplant Disorder and Sleep, run by Maksude YILDIRIM at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of therapeutic touch on sleep (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.