The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep

January 18, 2023 updated by: Ayse Arıcıoglu Sulun, Inonu University
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer is a disease characterized by rapid proliferation and uncontrollable growth of abnormal cells . According to the tumor statistics data of the Turkish Pediatric Oncology Group (TPOG), the incidence of cancer in children aged 10-14 in Turkey is 22.80 per million (n= 2756), while this rate is 7.35 per million in children aged 15-19 years (n= 2756). 886). Despite the high incidence of cancer, it has started to be seen as a life-threatening chronic disease rather than a terminal disease with the treatment methods developed in the field of pediatric oncology However, early initiation of treatment, effective treatment use, and high treatment success have made increasing the quality of life and psychosocial approach even more important. However, both cancer diagnosis and treatment reduce the child's quality of life and cause many psychosocial and physical problems.

Sleep plays a role in many important functions such as growth and development, tissue regeneration, energy conservation, and strengthening of the immune system in childhood.

Inadequate sleep quality and sleep disorders are frequently observed in children diagnosed with cancer . Sleep problems are seen in approximately half of children with cancer. Difficulty falling asleep, waking up suddenly during sleep, difficulty waking up, and excessive daytime sleepiness are symptoms that indicate inadequate sleep quality in children with cancer .

Sleep problems begin with the diagnosis of children with cancer, and the amount and quality of sleep of the child is negatively affected due to reasons such as unfamiliar environment, deterioration of sleep habits, and staying away from their own bed at the first admission to the clinic. In addition, symptoms such as side effects related to the treatment initiated, disruption of sleep routine due to treatment, and pain due to illness cause sleep problems . These sleep problems make it difficult for children to comply with treatment and reduce their quality of life.

Alternative pharmacological and non-pharmacological methods can be used in the management of cancer-related sleep disorders . Aromatherapy and listening to music are among the recommended non-pharmacological methods .

Arometherapy is a therapy method that is used frequently all over the world and that explores the use of essential oils to treat and protect the health of individuals .

Music concert is one of the methods aimed at improving the health and well-being of individuals. Although it has a positive effect on children physically, psychologically, socially and emotionally, it is an economical and side-effect-free method. No studies have been found in the literature evaluating the sleep status of children with cancer with music therapy.

There are studies in which aromatherapy and music therapy are applied in children with cancer.

Although there are studies reporting that aromatherapy and music therapy are effective in relieving the symptoms of children with cancer. In this direction, there is a need for studies that compare these methods with each other and have a high level of evidence, as well as the effectiveness of aromatherapy and music therapy in children with cancer.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Malatya
      • Battalgazi, Malatya, Turkey, 44100
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Being oriented, open to communication and cooperation

Exclusion Criteria:

- Not in the induction phase of cancer treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy
Aromatherapy will be done in the form of a 20-minute application period for three days.
Other: Aromatherapy
Aromatherapy: It will be applied to each child three times, three days in a row. Each application will be 20 minutes. The application time will be decided together with the patient. At the end of the three-day practice.
Experimental: music concert
"Music concert" will be performed in the form of a 20 minute daily practice period for three days.
Other: music concert
Music Concert: In this study, a music (lullaby, classical music) to be preferred by the patient or family Children are played for 20 minutes once a day. (morning or afternoon) for three days to help the child sleep. The volume of the music being played will be preserved. Aromatherapy: To be applied each child three times for three consecutive days. Each one The application will take 20 minutes. It will be time to implement The decision is made with the patient. Finally The patient's sleep quality will increase in three days of application. measured by actigraphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actigraphy device
Time Frame: three days
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 18, 2022

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020/165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: Bisson JI, van Gelderen M, Roberts NP, Lewis C. Non-pharmacological and non-psychological approaches to the treatment of PTSD: results of a systematic review and meta-analyses. Eur J Psychotraumatol [Internet]. 2020;11(1). Available from: https://doi.org/10.1080/20008198.2020.1795361

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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