## Protocol Section
### Identification Module
**NCT ID:** NCT06424093

**Brief Title:** Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy

**Official Title:** Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial

#### Organization Study ID Info
**ID:** Virtual Reality Technology
#### Organization
**Class:** INDUSTRY
**Full Name:** Egymedicalpedia
### Status Module
#### Completion Date
**Date:** 2024-11-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Egymedicalpedia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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:** 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 Module

**Conditions:**

- Acute Pain

- Anxiety

**Keywords:**

- hysteroscopy

- Acute Pain

- Anxiety

- Virtual Reality

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Virtual Reality Technology

**Label:** Group A: Cases Group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: Virtual Reality Technology

**Label:** Group B: Control Group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A: Cases Group

- Group B: Control Group

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

**Name:** Virtual Reality Technology

**Other Names:**

- Hysteroscopy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)

**Measure:** Assessment of Pain

**Time Frame:** 10 minutes from starting the procedure

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Waleed.shawky.94@gmail.com

**Name:** Waleed Mohamed shawky, MSC

**Phone:** +201093699004

**Role:** CONTACT

**Contact 2:**

**Email:** Tareksabry44444@gmail.com

**Name:** Tarek Sabry Mohamed, MSC

**Phone:** +201096398888

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** dr.a.zidan87@gmail.com

- **Name:** Ahmed Eid Elsayed Zidan, MSc

- **Phone:** +201067845518

- **Role:** CONTACT

***Contact 2:***

- **Email:** joseph.johny2010@gmail.com

- **Name:** Joseph Adel Ibrahim, MSc

- **Phone:** +201285515950

- **Role:** CONTACT

***Contact 3:***

- **Name:** Rania Gamal Anwar, Lecturer

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Yassin Asaad Mostafa, MSc

- **Role:** SUB_INVESTIGATOR

**Country:** Egypt

**Facility:** Ain Shams University Hospitals

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

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

**Name:** Amr Elhussieny, Professor

**Role:** STUDY_CHAIR

**Official 2:**

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

**Name:** Mortada El Sayed Ahmed, Professor

**Role:** STUDY_DIRECTOR

**Official 3:**

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

**Name:** Radwa Rsaheedy Ali, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29525

- Name: Acute Pain

- Relevance: HIGH

- As Found: Acute Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059787

- Term: Acute Pain

### Misc Info Module

- Version Holder: 2024-05-31
