Clinical trial NCT05164354: The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep
Official title: The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Sleep
Keywords: Pediatric cancer
sleep
aromatherapy
music concert
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: NAfter the pre-test is applied to the experimental group, music therapy and aromatherapy will be given to the experimental groups by the researcher.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

- Being oriented, open to communication and cooperation

Exclusion Criteria:

- Not in the induction phase of cancer treatment

Primary outcomes:
measure: Actigraphy device
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
city: Battalgazi
country: Turkey
facility: Inonu University
state: Malatya
Study officials:
References:
citation: Kutluk T YA. Turkish National Pediatric Cancer Registry 2002-2008. 41st Congress of International Society for Pediatric Oncology. Sao Paulo, Brazil. In: On behalf of Turkish Pediatric Oncology Group and Turkish Pediatric Hematology Society Turkish National Pediatric Cancer Registry 2002-2008 41st Congress of International Society for Pediatric Oncology Sao Paulo, Brazil. 2009. p. 851.
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