The Effect of Music Therapy on Nausea, Vomiting and Anxiety Levels in Children

NCT06224894 | Unknown

• 1 other identifier: BSEU-HSF
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted with a randomized controlled study model to examine the effect of music therapy on nausea, vomiting and anxiety levels in children diagnosed with oncological cancer receiving cisplatin. The research is planned to be carried out at Dokuz Eylül University Nevvar-Salih İşgören Children's Hospital Pediatric Hematology-Oncology Clinic between December 2023 and December 2024. There is no application for music therapy in the operation of this hospital and clinic.

Conditions

Music Therapy; Nausea; Anxiety; Cancer; Vomiting; Children, Only

Outcome Measures

Primary Outcomes (4)

• Child and Parent Information Form

  The form, created by the researchers using the literature, consists of 22 questions indicating the child's age, gender, diagnosis, treatment method, medication use other than chemotherapy, medications used, parent's age, parent's education, income and employment status, and characteristics of the child's care and treatment.

  one year

• Nausea Vomiting Thermometer for Children with Cancer

  It is a visual scale that measures nausea and vomiting developed by Kudubeş and Bektaş in 2022. The scale is thermometer-shaped and has five degrees. It is visualized as a smiling face (1), unresponsive face (2), sad face (3), sad face (4) and crying face (5). Additionally, as the scale score increases, the facial expression on the scale changes. It is scored as never (1), rarely (2), sometimes (3), often (4) and always (5). The lowest score from the scale is 1 and the highest score is 5. An increase in the scale score indicates that the child's degree of nausea and vomiting increases. The intraclass correlation coefficient of the scale is 0.99.

  one year

• Pediatric Rhodes Nausea and Vomiting Scale Adapted for Children:

  ARINVc was first developed for adult oncology patients by Rhodes and later adapted to children by Lo and Hayman. The validity and reliability study of the scale was conducted by Akçay and his colleagues in the Turkish population in 2018. The scale consists of five statements for each of 6 items measuring the child's frequency, duration and distress of nausea, frequency of vomiting and distress in the last 12 hours and is scored between 0 and 4. ARINVc consists of 6 items. The first three items in the scale question the frequency, amount, and distress caused by vomiting during the last 12 hours, and the remaining three items question the frequency, duration, and distress caused by nausea.

  one year

• State-Trait Anxiety Scale for Children

  The scale was developed by Spielberger in 1973. Its Turkish validity and reliability was conducted by Özusta in 1995 (Özusta, 1995). In the State Anxiety Scale of ÇDSCI, children are asked to evaluate how they feel 'at that moment' and to mark one of three relevant options. The scale, consisting of 20 items, aims to evaluate emotions related to state anxiety such as tension, irritability, and uneasiness. If the child reports the presence of these feelings as a lot, the highest score is 3, and if the child reports that they do not exist, the lowest score is 1.

  one year

Study Arms (2)

music therapy

EXPERIMENTAL

The child in the music therapy group will receive a standard antiemetic treatment procedure 15 minutes before the cisplatin infusion. Music therapy will be applied with the start of cisplatin infusion. The song "The Happiest Child", developed by creating rhythms and developed by Fulya Merve KOS, a researcher with a RhythmotherapistTM certificate issued by the Ministry of National Education, will be used in music therapy. The sound will be adjusted to 45 db. The speaker will be placed at the end of the foot, approximately 30 cm from the child's ear, five minutes before the procedure and will be played to the child during the procedure. After the infusion, music therapy will be terminated and the level of nausea, irritability and anxiety will be evaluated with data collection forms.

Other: Music Therapy; Other: antiemetic treatment

antiemetic treatment

EXPERIMENTAL

Standard approach; Granisetron IV 40mcg/kg/24, Aprepitant PO 125 mg/24 hour and Dexamethasone 6 mg/m2 IV/PO are administered to children receiving cisplatin treatment.

Other: antiemetic treatment

Interventions

Music Therapy OTHER

Music Therapy

music therapy

antiemetic treatment OTHER

antiemetic treatment

antiemetic treatment; music therapy

Eligibility Criteria

• Age: 7 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Those between the ages of 7-18,
• Receiving Cisplatin Treatment, Diagnosed with Oncological Cancer,
• Without Mental Retardation as a Clinical Diagnosis,
• Those who received chemotherapy during their stay in the clinic,
• No Hearing Problems,
• Able to Read and Write Turkish,
• Children with Cancer who Volunteer to Participate in the Research

You may not qualify if:

• Children with cancer who are in the terminal period and do not want to participate in the study will not be included in the study.

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

MeSH Terms

Conditions

Nausea; Anxiety Disorders; Neoplasms; Vomiting

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 25, 2024
• Study Start: February 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 25, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share