Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy

NCT ID: NCT06424093

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider.

Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.

Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.

Although a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.

The studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.

Nonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pain Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: Cases Group

About 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology

Group Type EXPERIMENTAL

Virtual Reality Technology

Intervention Type PROCEDURE

To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy

Group B: Control Group

About 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology

Group Type PLACEBO_COMPARATOR

Virtual Reality Technology

Intervention Type PROCEDURE

To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Technology

To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hysteroscopy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB

Exclusion Criteria

* Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.
* Psychological ,hearing or visual disorders.
* known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .
* Previous history of failed office hysteroscopy
* Patients scheduled for operative hysteroscopy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Egymedicalpedia

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amr Elhussieny, Professor

Role: STUDY_CHAIR

Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University

Mortada El Sayed Ahmed, Professor

Role: STUDY_DIRECTOR

Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University

Radwa Rsaheedy Ali, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Waleed Mohamed shawky, MSC

Role: CONTACT

+201093699004

Tarek Sabry Mohamed, MSC

Role: CONTACT

+201096398888

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed Eid Elsayed Zidan, MSc

Role: primary

+201067845518

Joseph Adel Ibrahim, MSc

Role: backup

+201285515950

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Virtual Reality Technology

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.