Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy

NCT05514236 | Completed

• 1 other identifier: CRE 2022.237
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Outpatient hysteroscopy is an essential diagnostic procedure for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding, to evaluate any intrauterine pathologies. It also serves as a therapeutic procedure such as removal of fibroids, polyps or intrauterine devices.However, the most common reason for procedure failure is pain. On such occasions, the procedure has to be re-arranged in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce patients' health care experience, patients' anesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to patients. This randomized controlled trial aims at evaluating the effectiveness of non-pharmacological interventions (virtual reality and music therapy) in pain management during hysteroscopy. It can hopefully provide more clinical data to explore the role of non-pharmacological techniques in outpatient hysteroscopy pain control, hence help improve our participants' experience in outpatient hysteroscopy.

Conditions

Pain Management; Hysteroscopy

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.

  Passage of hysteroscope through cervical internal os and during the assessment of uterine cavity of each participant. The study will be 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.

  Passage of hysteroscope through cervical internal os and during the assessment of uterine cavity of each participant. The study will be up to 1.5 years.

Study Arms (3)

Virtual reality group

EXPERIMENTAL

Participants assigned to the Visual reality group will be given the virtual reality device (a headset) with immersive video content for use during the hysteroscopy. Designated moving objects with sound will be broadcasted on the screen to the participant in this group. Participant can adjust the volume of the sound according to her comfort.

Other: Virtual Reality Therapy

Music group

EXPERIMENTAL

Participants in the music group will be given a headphone playing either classical light music or 'POP' songs according to their option during the hysteroscopy. Participant can adjust the volume of the sound according to her comfort.

Other: Music Therapy

Control group

NO INTERVENTION

While participants in the control group will not be given any Virtual reality or music device.

Interventions

Virtual Reality Therapy OTHER

Participants will be given the virtual reality device (a headset) with immersive video content for use during the hysteroscopy. Designated moving objects with sound will be broadcasted on the screen to the participant in this group. Participant can adjust the volume of the sound according to her comfort.

Virtual reality group

Music Therapy OTHER

Participants will be given a headphone playing either classical light music or 'POP' songs according to their option during the hysteroscopy. Participant can adjust the volume of the music according to her comfort.

Music group

Eligibility Criteria

• Age: 18 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

Location

MeSH Terms

Conditions

Agnosia

Interventions

Virtual Reality Exposure Therapy; Music Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• KA MAN YiP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

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: August 16, 2022
• First Posted: August 24, 2022
• Study Start: September 21, 2022
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)