Effect of Music Therapy on Pain and Anxiety Levels in Women undergoing visualisation of the inside of uterine cavity

Completed

• Conditions: Abnormal uterine and vaginal bleeding, unspecified,

• Registration Number: CTRI/2022/04/041947
• Lead Sponsor: AIIMS New Delhi

Brief Summary

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|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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-10
• Study Start: 2022-02-05
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients with post-menopausal bleeding 2.
• Abnormal uterine bleeding 3.
• Patients with primary infertility 4.
• Secondary infertility.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The effect of background music as a complimentary factor in relieving pain	1. At the end of the procedure for each patient | 2. Overall outcome will be assesed at the end of 6 months
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 Measures

Name	Time	Method
Time taken per procedure by the surgeonsin the presence of background music during office hysteroscopy procedures	2 months and 6 months

Trial Locations

Locations (1)

All India Institute of Medical Sciences New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences New Delhi

🇮🇳South, DELHI, India

Rinchen Zangmo

Principal investigator

9910557436

rinchhen.zn@gmail.com