NCT07152938

Brief Summary

The main purpose of this study is to examine the effect of using AVR on pain, stress, anxiety, and SE among adult cancer patients undergoing chemotherapy in the West Bank hospitals in Palestine. The main questions it aims to answer are:

  1. 1.What is the effect of AVR therapy on pain levels score compared with routine care during chemotherapy session among cancer patients?
  2. 2.What is the effect of AVR therapy on the stress levels compared with routine care during chemotherapy session among cancer patients?
  3. 3.What is the effect of AVR therapy on the anxiety compared with routine care during chemotherapy session among cancer patients?
  4. 4.What is the effect of AVR therapy on the general SE compared with routine care during chemotherapy session among cancer patients?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 26, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Augmented Virtual RealityPain ManagementStressAnxietySelf-EfficacyChemotherapyPalestine

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity during chemotherapy

    Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. The outcome will be the change in NPRS score from immediately before to immediately after the chemotherapy session, comparing the AVR intervention group with the control group.

    Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).

Secondary Outcomes (3)

  • Change in self-efficacy during chemotherapy

    Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).

  • Change in perceived stress during chemotherapy

    Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).

  • Change in anxiety symptoms during chemotherapy

    Immediately before chemotherapy and immediately after the session (June 2023 - September 2023).

Study Arms (2)

Control Group (Standard Chemotherapy Care)

NO INTERVENTION

the control group participated in routine sessions without AVR. Patients were admitted to the daycare unit, where a cannula was applied. The nurse then followed the doctor's order for the type of medication that would be given to the patient. Subsequently, the patients filled out the questionnaire at the posttest.

AVR Group

EXPERIMENTAL

Patients receive standard chemotherapy care plus Augmented Virtual Reality (AVR) distraction sessions during chemotherapy infusion.

Behavioral: AVR Group (Chemotherapy + AVR)

Interventions

the intervention group received AVR before they started treatment and during the session. The researcher administered the posttest questionnaire The questionnaire assessed immediately after finishing AVR. Participants informed not to discuss AVR with each other's, as the researcher explained to the participants the purpose of the study and their participation will not affect their care or treatment

AVR Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged 18-60 years undergoing chemotherapy for breast or colon cancer.
  • Stage I or II cancer, as defined by the study protocol.
  • Manageable levels of pain, anxiety, and stress, appropriate for participation in the intervention.

You may not qualify if:

  • Age over 60 years.
  • Cancer types other than breast or colon cancer.
  • Severe pain, anxiety, or stress that could interfere with participation or require intensive care beyond the study scope.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jenin governmental hospital

Jenin, 00970, Palestinian Territories

Location

AL-Watni governmental hospital

Nablus, 00970, Palestinian Territories

Location

Thabet Thabet governmental hospital

Tulkarm, 00970, Palestinian Territories

Location

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsBreast NeoplasmsLymphomaMultiple MyelomaAgnosiaAnxiety Disorders

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: participants randomly assigned to either the intervention group(augmented virtual reality sessions)or the other control group( standard care)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
academic lecturer

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 3, 2025

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data did not shared due to patient privacy concerns and the absence of a secure data repository. Only aggregated and anonymized study results made available in publications and presentations

Locations