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Effect of Virtual Reality and Music Therapy on Pain Relief in OPH Operations

NCT05751811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-08-26

No results posted yet for this study

Summary

Outpatient hysteroscopy can serve as a diagnostic procedure to evaluate for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding. This study focuses on the therapeutic aspect of outpatient hysteroscopy, such as myomectomy, polypectomy, intrauterine adhesiolysis and removal of lost intrauterine devices, etc. Apart from the conventional polyp scissors and biopsy forceps, there are also emerging hysterscopic tissue removal systems, such as Truclear®, that can decrease the operation time and increase success of outpatient hysteroscopic operations.

On such occasions, the outpatient hysteroscopic operation needs to be re-arranged in an inpatient setting in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce participants' health care experience, participants' anaesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to participants.

This randomized controlled trial aims at evaluating the effectiveness of non-pharmacological interventions (virtual reality and music therapy) in pain management during hysteroscopic operations. It can hopefully provide more local clinical data to explore the role of nonpharmacological techniques in pain control, hence improve our participants' experience in hysteroscopic operations and the potential of providing more hysteroscopic operations as an outpatient setting.

Conditions

Interventions

DEVICE

Virtual reality

The immersive video simulated a magical journey through a calming starry sky on a flying carpet. The headset will play the immersive video content throughout the hysteroscopic procedure; and will stop playing the content as the procedure comes to an end. Participant can adjust the volume of the sound according to her comfort. The duration of hysteroscopic operation will be 5 to 20 minutes.

PROCEDURE

Music therapy

Relaxing and light music will play throughout the hysteroscopic procedure; and will stop playing as the procedure comes to an end. Participant can adjust the volume of the sound according to her comfort. The duration of hysteroscopic operation will be 5 to 20 minutes.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Tze Yan Wong · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751811 on ClinicalTrials.gov