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

NCT05751811 | Recruiting

• 1 other identifier: CRE 2022.617
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Pain relief; Hysteroscopy

Outcome Measures

Primary Outcomes (2)

• The change of the pain score of virtual reality therapy compared to control group (no intervention) in outpatient hysteroscopy.

  The change of the pain score of virtual reality therapy at different time-point during outpatient hysteroscopy, compared to control group (no intervention). Pain score from 0 to 10, with 0 being no pain and 10 the most severe pain.

  up to 1.5 years

• The change of the pain score of music therapy compared to control group (no intervention) in outpatient hysteroscopy.

  The change of the pain score of music therapy at different time-point during outpatient hysteroscopy, compared to control group (no intervention). Pain score from 0 to 10, with 0 being no pain and 10 the most severe pain.

  up to 1.5 years

Study Arms (3)

Virtual reality group

EXPERIMENTAL

Participants under Virtual reality group will wear a virtual reality headset with immersive video content during the whole hysteroscopy.

Device: Virtual reality

Music therapy group

EXPERIMENTAL

Participants under Music therapy group will wear a headphone playing music during the whole hysteroscopy.

Procedure: Music therapy

Control group

NO INTERVENTION

Participants under Control group will proceed with hysteroscopy as usual practise.

Interventions

Virtual reality DEVICE

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.

Virtual reality group

Music therapy PROCEDURE

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.

Music therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants scheduled for outpatient hysteroscopy in Prince of Wales Hospital.
• Participants who are willing to give written consent to participate in the study.

You may not qualify if:

• Participants who have hearing or visual deficits.
• Participants who cannot understand written Chinese.
• Participants refuse to participate in the study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tze Yan Wong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tze Yan Wong

CONTACT

3505 2806; yannytywong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: July 13, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

HK (1)