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Clinical Trials/CTRI/2022/04/041947
CTRI/2022/04/041947CompletedNot Applicable

Effect of Music Therapy on Pain and Anxiety Levels in Women undergoing Office Hysteroscopy

AIIMS New Delhi1 site in 1 country80 target enrollmentStarted: February 5, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
1.The effect of background music as a complimentary factor in relieving pain
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
25.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

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

Exclusion Criteria

  • •Patients with hearing impairment
  • •Previous cervical procedures like conization, Manchester Fothergills procedure
  • •Cervical stenosis
  • •Retroverted uterus
  • •Patients with anxiety disorder on medication.

Outcomes

Primary Outcomes

1.The effect of background music as a complimentary factor in relieving pain

Time Frame: 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.

Time Frame: 1. At the end of the procedure for each patient | 2. Overall outcome will be assesed at the end of 6 months

Secondary Outcomes

  • Time taken per procedure by the surgeonsin the presence of background music during office hysteroscopy procedures(2 months and 6 months)

Investigators

Sponsor
AIIMS New Delhi
Sponsor Class
Government medical college

Study Sites (1)

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