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IRCT20251121068065N4 IRCT 2026-06-10 University of Mazandaran The effect of relaxation-based virtual reality on the psychological indicators of athletes with knee injuries The effect of relaxation-based virtual reality on the psychological indicators of athletes with knee injuries 2026-07-01 anticipated 30 Recruiting https://irct.ir/trial/90660 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Anterior Cruciate Ligament (ACL) Injury Following Reconstruction Surgery. Intervention 1: 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 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Masoumeh Ghorbani Marzuni
University of Mazandaran, Pasdaran Street, Babolsar, Mazandaran Province, Iran.
Babolsar Iran (Islamic Republic of) 47416-13534 +98 11 3530 2215 ghorbani.m@umz.ac.ir University of Mazandaran scientific Masoumeh Ghorbani Marzuni
University of Mazandaran, Pasdaran Street, Babolsar, Mazandaran Province, Iran.
Babolsar Iran (Islamic Republic of) 47416-13534 +98 11 3530 2215 ghorbani.m@umz.ac.ir University of Mazandaran Iran (Islamic Republic of) 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. 24 years 34 years Male 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. S83.5 Sprain and strain of cruciate ligament of knee (Anterior Cruciate Ligament injury) Rehabilitation Rehabilitation 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. Conventional physiotherapy will include electrotherapy, range-of-motion exercises, muscle strengthening, and functional rehabilitation exercises. 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. 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. 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. 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. 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. University of Mazandaran Approved 2024-12-28 Research Ethics Committee of University of Mazandaran University of Mazandaran, Pasdaran Street, Babolsar, Mazandaran Province, Iran. Babolsar Mazandaran Iran (Islamic Republic of)