| CTRI Number |
CTRI/2024/04/065618 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral
Other (Specify) [Instrumental Music] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Music therapy for sleep problems
in children with cancer at home |
|
Scientific Title of Study
|
Role of music therapy for sleep disturbances in Pediatric
Oncology patients in Home based setting |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIKSHA SINGH |
| Designation |
MBBS III Year Student |
| Affiliation |
Government Medical College and Hospital , Aurangabad |
| Address |
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7506741020 |
| Fax |
|
| Email |
dikshasingh883@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SMITA MUNDADA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Government Medical College and Hospital , Aurangabad |
| Address |
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
09224287215 |
| Fax |
|
| Email |
smita.mundada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIKSHA SINGH |
| Designation |
MBBS III Year Student |
| Affiliation |
Government Medical College and Hospital , Aurangabad |
| Address |
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
DEPARTMENT OF PAEDIATRICS,ward no 24 , 2nd floor,Surgical building, Government Medical College Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7506741020 |
| Fax |
|
| Email |
dikshasingh883@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Cancer Hospital , Aurangabad |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Cancer Hospital , Aurangabad |
| Address |
Buddi Lane , near Aamkhas Maidan , Narali Bagh , Aurangabad , Maharashtra 431005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Diksha Singh |
Government Cancer Hospital , Aurangabad |
Pediatric OPD , ground floor , Buddi Lane , near Aamkhas Maidan , Naralibag , Aurangabad, 431005
Aurangabad
MAHARASHTRA |
7506741020
dikshasingh883@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- IEC GMCA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C96Z||Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrumental music |
Instrumental music to be heard by the cases 5 days / week for 15 minutes before going to sleep for 1 month |
| Comparator Agent |
Routine care |
Routine maintenance care provided |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Having sleep disturbances in Childrens Sleep Habit Questionnaire score greater than 41.
2 Whose duration of diagnosis is more than one month will be included. |
|
| ExclusionCriteria |
| Details |
1. Parents/ Caregivers who did not give consent for participation.
2.Children receiving palliative care.
3.Children with severe cognitive disorders/intellectual disabilities.
4.Children who had anatomical sleep breathing disorders.
5.Children having severe hearing impairment.
6.Parents/caregivers who do not own a music distribution device. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Care giver or observor Reported improvement in sleep quality measured by CSHQ (child sleep habit questionnaire) |
AT BASELINE AND AT THE END OF 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.INCREASE IN TOTAL SLEEP TIME AS COMPARED TO BASELINE
2.DECREASE IN SLEEP ONSET LATENCY |
AT BASELINE AND AT THE END OF 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in the pediatric oncology department in a government tertiary care hospital. After getting approval from the Institutional Ethical Committee, all those fulfilling the inclusion criteria will be enrolled in the study over the specified duration. All participants and their parents/caregivers will be informed and explained about the study, and consent will be obtained in their mother tongue. All interviews will be face-to-face using a pre-structured questionnaire. The primary socio-demographic data will be collected in the survey, such as gender, Age, type of family, parent’s education, and socioeconomic class of family. Data about cancer therapy like the type of cancer, stage of cancer, and chemotherapy drugs will be recorded. Participants will be allocated into control and case groups alternatively.Parents/caregivers of all participants in both groups will complete the Children’s Sleep Habit Questionnaire ( CSHQ ). CSHQ is a 45-item questionnaire to identify sleep behavior in children. The answers will be recorded on a three-point scale. The cut-off for significant sleep disorder will be considered as values > 41. After enrollment, the control group will receive routine care and sleep hygiene education. In addition, the test group will be provided instrumental music played on an MP3 player with earphones for 15 minutes before bedtime. YouTube (2018b). Lullabies Retrieved from https://www.youtube.com/watch? v=I0R5b4YJHwo ]. A sleep diary will be given to the parents to monitor their children’s sleep time, children’s mood on waking up in the morning, and music therapy given or not over four weeks. ( attached )They will be instructed to follow the music therapy for at least five days/week for four weeks. We will send text message reminders to the parents/caregivers of children. Children will be assessed with a Structured questionnaire, CSHQ, and sleep diaries again at the end of 4 weeks. Things provided to parents : 1. MP3 Relaxing music audio 2. Sleep diary• |