To investigate the effect of virtual reality–based relaxation on psychological outcomes in athletes with knee injuries.
Design
This study is a randomized controlled, pretest–posttest trial. Thirty male athletes in the early phase of rehabilitation following anterior cruciate ligament reconstruction will be recruited through convenience sampling and randomly allocated (1:1) to either the intervention group or the control group using a computer-generated simple randomization sequence.
Settings and conduct
This study will be conducted at a physiotherapy clinic in Sari, Iran. Eligible participants will be randomly assigned to intervention or control groups, and psychological outcomes will be assessed before and after the intervention.
Participants/Inclusion and exclusion criteria
Male athletes aged 24–34 years who have undergone anterior cruciate ligament reconstruction and are in the early phase of rehabilitation will be eligible. Participants must have a history of regular exercise and be willing to complete the study. Individuals with concurrent injuries, severe pre-existing psychological disorders, poor adherence to the intervention, or absence from study sessions will be excluded.
Intervention groups
Control Group:Participants will receive routine physiotherapy alone, including electrotherapy, range-of-motion exercises, muscle strengthening, and functional rehabilitation exercises, without virtual reality–based relaxation.
Intervention Group: Participants will receive routine physiotherapy combined with virtual reality–based relaxation. During physiotherapy sessions, participants will use virtual reality glasses to view immersive nature-based relaxation videos designed to promote psychological relaxation.
Main outcome variables
1-Depression Indicators
2- Anxiety
3-Pain
4-Fear of Movement
5-Fear of Re-Injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251121068065N4
Registration date:2026-06-10, 1405/03/20
Registration timing:prospective
Last update:2026-06-10, 1405/03/20
Update count:0
Registration date
2026-06-10, 1405/03/20
Registrant information
Name
kavoushgaran kavoushgaran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 718 4680
Email address
atiye.hesary@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-01, 1405/04/10
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of relaxation-based virtual reality on the psychological indicators of athletes with knee injuries
Public title
The effect of relaxation-based virtual reality on the psychological indicators of athletes with knee injuries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male athletes aged 24–34 years.
History of anterior cruciate ligament (ACL) reconstruction surgery.
History of regular exercise participation during the previous three years.
Being in the early phase of postoperative rehabilitation.
Referral to the selected physiotherapy clinic and willingness to participate throughout the study.
Exclusion criteria:
Age outside the specified range.
Presence of concurrent musculoskeletal injuries other than ACL-related injuries.
History of severe psychological disorders before injury.
Failure to adhere to the prescribed intervention program.
bsence from intervention or assessment sessions.
Age
From 24 years old to 34 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be enrolled through convenience sampling and subsequently allocated to the intervention group (physiotherapy plus virtual reality–based relaxation) or the control group (physiotherapy alone) using simple randomization. The randomization sequence will be generated using a randomization program based on the research website https://www.randomizer.org. Group allocation will be performed according to the generated sequence to ensure equal probability of allocation for all participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of University of Mazandaran
Street address
University of Mazandaran, Pasdaran Street, Babolsar, Mazandaran Province, Iran.
City
Babolsar
Province
Mazandaran
Postal code
47416-13534
Approval date
2024-12-28, 1403/10/08
Ethics committee reference number
IR.UMZ.REC.1403.094
Health conditions studied
1
Description of health condition studied
Anterior Cruciate Ligament (ACL) Injury Following Reconstruction Surgery
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain of cruciate ligament of knee (Anterior Cruciate Ligament injury)
Primary outcomes
1
Description
Anxiety and depression
Timepoint
Depression and anxiety will be assessed at two time points: baseline (pre-test, before the intervention) and immediately after completion of the intervention period (post-test).
Method of measurement
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). This is a 14-item self-report questionnaire with two subscales measuring anxiety (7 items) and depression (7 items). Each item is scored on a 4-point Likert scale (0–3), with higher scores indicating greater symptom severity. A total score above 11 is considered clinically significant. The validated Persian version of the HADS will be used in this study.
2
Description
Pain intensity
Timepoint
Pain intensity will be assessed at two time points: baseline (pre-test, before the intervention) and immediately after completion of the intervention period (post-test).
Method of measurement
Pain will be assessed using the McGill Pain Questionnaire (MPQ), a validated multidimensional self-report instrument designed to evaluate the sensory and affective dimensions of pain perception. The questionnaire consists of 20 items covering different aspects of pain experience, including sensory qualities (items 1–10), affective/emotional responses (items 11–15), evaluative aspects (item 16), and miscellaneous pain descriptors (items 17–20). Responses are recorded using a structured rating format, and higher scores indicate greater pain intensity and affective distress.
3
Description
Fear of movement (Kinesiophobia)
Timepoint
Fear of movement will be assessed at two time points: baseline (pre-test, before the intervention) and immediately after completion of the intervention period (post-test).
Method of measurement
Fear of movement will be assessed using the Tampa Scale for Kinesiophobia (TSK-11), an 11-item validated self-report questionnaire designed to measure fear of movement and (re)injury-related avoidance beliefs. The scale includes two subdomains: fear of injury (items 1–6) and activity avoidance (items 7–11). Each item is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater fear of movement. The TSK-11 has demonstrated acceptable psychometric properties, including good internal consistency in previous research.
4
Description
Fear of re-injury
Timepoint
Fear of re-injury will be assessed at two time points:baseline (pre-test, before the intervention) and immediately after completion of the intervention period (post-test).
Method of measurement
Fear of re-injury will be assessed using a validated self-report questionnaire designed to measure fear of re-injury following sports injury, completed by participants.
Secondary outcomes
1
Description
Pain-related avoidance beliefs and cognitive perceptions of pain
Timepoint
Pain-related avoidance beliefs and cognitive perceptions of pain will be measured at two time points: baseline (pre-test, before intervention) and immediately after the end of the intervention period (post-test).
Method of measurement
Pain avoidance beliefs will be assessed using the questionnaire on avoidance beliefs about pain during work and physical activity, a 16-item self-report instrument developed by Asghari Moghadam et al. The questionnaire evaluates four dimensions: belief in pain persistence, self-blame, stability of pain, and unpredictability of pain. Items are completed by participants, and higher scores indicate stronger maladaptive avoidance beliefs.
Intervention groups
1
Description
Control group: Participants will receive routine physiotherapy alone, including electrotherapy, range-of-motion exercises, muscle strengthening, and functional rehabilitation exercises, without virtual reality–based relaxation.
Category
Rehabilitation
2
Description
Intervention group: Participants will receive routine physiotherapy combined with virtual reality–based relaxation. During physiotherapy sessions, participants will use virtual reality glasses to view immersive nature-based relaxation videos designed to promote psychological relaxation. Conventional physiotherapy will include electrotherapy, range-of-motion exercises, muscle strengthening, and functional rehabilitation exercises.