Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy

NCT07677436 | Not Yet Recruiting

• 1 other identifier: VRGI-PhD-2026
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care

Conditions

Virtual Reality; Guided Imagery; Breast Cancer; Chemotherapy; Pain; Anxiety; Fatigue

Keywords

Virtual Reality, Guided Imagery , Breast Cancer, Chemotherapy , Pain, Anxiety , Fatigue

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 scale where higher scores indicate greater pain severity. The assessment will be conducted at baseline and after the intervention period to evaluate changes in pain levels between the intervention and control groups.

  Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

Secondary Outcomes (2)

• Anxiety level

  Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

• Fatigue level

  Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

Study Arms (2)

Virtual Reality-Guided Imagery plus Routine Care

EXPERIMENTAL

Participants in this group will receive guided virtual reality mindfulness sessions, in addition to their routine chemotherapy care. This intervention is a non-pharmaceutical supportive approach designed to reduce pain, anxiety, and fatigue through immersive guided mindfulness and relaxation during chemotherapy cycles.

Device: Virtual Reality-Guided Imagery

Routine Care Only

NO INTERVENTION

Participants in this arm will receive routine chemotherapy care only without virtual reality-guided imagery intervention.

Interventions

Virtual Reality-Guided Imagery DEVICE

The intervention consists of immersive virtual reality-guided imagery delivered using a commercially available VR headset and pre-designed guided imagery software. Participants will wear the VR headset during chemotherapy sessions, which provides access to pre-recorded guided imagery programs. These programs include standardized audiovisual content such as calming natural scenes, relaxation instructions, and breathing guidance designed to promote relaxation and distraction from pain, anxiety, and fatigue. The content is not developed by the researcher but is selected from existing validated or commercially available VR applications. Each session will be administered under supervision during chemotherapy and in addition to routine hospital care. The intervention aims to reduce symptom burden by shifting the patient's attention away from treatment-related discomfort through immersive guided imagery experiences.

Also known as: Immersive Virtual Reality, Guided imagery therapy

Virtual Reality-Guided Imagery plus Routine Care

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18 years or older.
• Histologically confirmed breast cancer.
• Stage I, II, or III breast cancer.
• Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).
• Able to read, write, and communicate.
• Able and willing to use a virtual reality headset.
• Able to provide written informed consent.

You may not qualify if:

• Visual or hearing impairment that prevents the use of virtual reality.
• Serious neurological or psychiatric disorders.
• Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.
• Previous experience with virtual reality-guided imagery.
• Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.

Sponsors & Collaborators

• Thoalfokar Mohammed Al-Obaidi: lead

Study Sites (1)

National Hospital for Oncology and Hematology in Najaf Governorate

Najaf, Najaf Governorate, Iraq

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

thulfiqar mohammed abdalhussien, PhD candidate

CONTACT

07831476489; thulfiqar.abd2402p@conursing.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is single-blinded. Due to the nature of the intervention, participants will be aware of whether they receive virtual reality-guided imagery or routine care. However, the outcome assessor responsible for collecting and evaluating study data will be blinded to group allocation to minimize assessment bias. This approach is used to ensure objectivity in outcome measurement and improve the internal validity of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Model Details: This study uses a parallel-group randomized controlled trial design. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive virtual reality-guided imagery in addition to routine care, while the control group will receive routine care only. Both groups will be followed concurrently during the study period, and outcomes will be assessed at baseline and post-intervention to compare changes between groups.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)