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

NCT05164354 | Completed

• 1 other identifier: 2020/165
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Sleep

Keywords

Pediatric cancer; sleep; aromatherapy; music concert

Outcome Measures

Primary Outcomes (1)

• Actigraphy device

  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

Study Arms (2)

Aromatherapy

EXPERIMENTAL

Aromatherapy will be done in the form of a 20-minute application period for three days.

Other: Aromatherapy

music concert

EXPERIMENTAL

"Music concert" will be performed in the form of a 20 minute daily practice period for three days.

Other: music concert

Interventions

Aromatherapy OTHER

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.

Aromatherapy

music concert OTHER

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.

music concert

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Being oriented, open to communication and cooperation

You may not qualify if:

• \- Not in the induction phase of cancer treatment

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Battalgazi, Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  BACKGROUND

• Kudubeş AA, Bektas M, Bektas İ, Selekoglu Y, Sal Altan S, Ayar D. The effect of symptom frequency on the fatigue and sleep quality of adolescent cancer patients. Child Heal Care. 2017;46(4):421-38.

  BACKGROUND

• Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13.

  PMID: 25679070 BACKGROUND

• Kaleyias J, Manley P, Kothare SV. Sleep disorders in children with cancer. Semin Pediatr Neurol. 2012 Mar;19(1):25-34. doi: 10.1016/j.spen.2012.02.013.

  PMID: 22641073 BACKGROUND

• Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.

  PMID: 29663636 BACKGROUND

• Kushner BH, LaQuaglia MP, Wollner N, Meyers PA, Lindsley KL, Ghavimi F, Merchant TE, Boulad F, Cheung NK, Bonilla MA, Crouch G, Kelleher JF Jr, Steinherz PG, Gerald WL. Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy. J Clin Oncol. 1996 May;14(5):1526-31. doi: 10.1200/JCO.1996.14.5.1526.

  PMID: 8622067 BACKGROUND

• Allen JM, Graef DM, Ehrentraut JH, Tynes BL, Crabtree VM. Sleep and Pain in Pediatric Illness: A Conceptual Review. CNS Neurosci Ther. 2016 Nov;22(11):880-893. doi: 10.1111/cns.12583. Epub 2016 Jul 15.

  PMID: 27421251 BACKGROUND

• American Cancer Society. Cancer Facts & Figures 2016. Cancer Facts Fig 2016. 2016;1-9.

  RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Research Asistant

Model Details: NAfter the pre-test is applied to the experimental group, music therapy and aromatherapy will be given to the experimental groups by the researcher.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 20, 2021
• Study Start: April 1, 2020
• Primary Completion: May 18, 2022
• Study Completion: June 29, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)