| CTRI Number |
CTRI/2022/04/041947 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Music Therapy on Pain and Anxiety Levels in Women undergoing visualisation of the inside of uterine cavity |
|
Scientific Title of Study
|
Effect of Music Therapy on Pain and Anxiety Levels in Women undergoing Office Hysteroscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rinchen Zangmo |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
09910557436 |
| Fax |
|
| Email |
rinchhen.zn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rinchen Zangmo |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
09910557436 |
| Fax |
|
| Email |
rinchhen.zn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rinchen Zangmo |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
09910557436 |
| Fax |
|
| Email |
rinchhen.zn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar |
| 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 |
| Rinchen Zangmo |
All India Institute of Medical Sciences New Delhi |
Room 3077 Department of Obstetrics and Gynaecology
South
DELHI |
9910557436
rinchhen.zn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics comittee AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music therapy |
this group will receive music therapy during the office hysteroscopy procedure. Duration of therapy will be from the start of the procedure till the end of the procedure, around 5 to 10 minutes |
| Comparator Agent |
No music therapy |
The Comparator group will not receive music therapy |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with post-menopausal bleeding
2. Abnormal uterine bleeding
3. Patients with primary infertility
4. Secondary infertility
|
|
| ExclusionCriteria |
| Details |
1. Patients with hearing impairment
2. Previous cervical procedures like conization, Manchester Fothergills procedure
3. Cervical stenosis
4. Retroverted uterus
5. Patients with anxiety disorder on medication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The effect of background music as a complimentary factor in relieving pain
2. The effect of background music on relieving anxiety in patients undergoing office hysteroscopy.
|
1. At the end of the procedure for each patient
2. Overall outcome will be assesed at the end of 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken per procedure by the surgeonsin the presence of background music during office hysteroscopy procedures |
2 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2022 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hysteroscopy plays a crucial role in the evaluation of the uterine cavity in women with abnormal uterine bleeding and infertility. Advancements in both the procedure and the instrument has enabled its use in the office context. As an office procedure, it gives comparable results to inpatient hysteroscopy, with the advantages of lower costs and avoidance of anaesthetic risks. The main disadvantage of the use of office hysteroscopy is the pain experienced by the patient, there is still paucity of data on effective technique to reduce pain. Also, any surgical procedure be it diagnostic or operative causes some level of anxiety in the patients. This study aims to evaluate the effect of music therapy during office hysteroscopy in improving pain and anxiety experienced by the patient during office hysteroscopy. It also aims to study the satisfaction rate among doctors and patients with or without music therapy. |
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