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IRCT20251022067726N1 IRCT 2025-11-12 Zahedan University of Medical Sciences The Effect of Progressive Muscle Relaxation on Fatigue, Functional Ability, and Health Anxiety in Patients after Ischemic Stroke The Effect of Progressive Muscle Relaxation on Fatigue, Functional Ability, and Health Anxiety in Hospitalized Patients after Ischemic Stroke 2025-11-29 anticipated 120 Complete https://irct.ir/trial/87080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients diagnosed with ischemic stroke who meet the inclusion criteria will be selected using a convenience sampling method upon admission to the ward. After obtaining written informed consent, each eligible patient will be enrolled as a participant in the study. The allocation of patients into the intervention and control groups will be performed randomly and immediately after admission. To achieve this, a number of sealed envelopes containing pre-assigned numbers will be placed in a bag, and one of the ward staff members will randomly draw an envelope for each patient. Based on the assigned number, patients with even numbers will be allocated to the control group (receiving routine care), while those with odd numbers will be allocated to the intervention group (receiving progressive muscle relaxation training). The randomization process will be conducted at the time of hospitalization and prior to the initiation of any intervention to prevent allocation bias and ensure baseline balance between the study groups, Blinding description: In this study, the functional ability of patients in both the intervention and control groups will be assessed on the first day of hospitalization, on the fifth day of hospitalization at the time of discharge, and again four weeks after discharge. Functional status will be measured using the Barthel Index through direct observation or patient interview (and when communication difficulties are present, through an informed caregiver). All assessments will be conducted by an independent evaluator, selected from among master's-level nursing students, who will be blinded to the study details (Blinded Assessor) in order to minimize bias in data collection. N/A Ischemic Stroke. Intervention 1: Intervention group: The intervention group will undergo progressive muscle relaxation (PMR) training conducted by a trained researcher for five consecutive days. The training sessions will be delivered individually, face-to-face, once daily during the morning shift, and will last approximately 20–30 minutes at the patient’s bedside in the neurology ward. Each session involves the sequential tensing and relaxing of different muscle groups. Patients will be positioned supine, and the exercises will be performed in the following order:1. Raise the eyebrows.2. Close the eyes tightly.3. Clench the jaw and pull the corners of the mouth backward.4. Bring the chin toward the chest (without contact).5. Make a fist with the dominant hand.6. Press the dominant elbow against the body.7. Make a fist with the non-dominant hand.8. Press the non-dominant elbow against the body.9. Pull the shoulders backward, take a deep breath, and hold it.10. Contract the abdomen.11. Lift the dominant leg slightly off the bed and hold.12. Point the toes of the dominant foot upward.13. Flex the toes of the dominant foot toward the sole and then release.14. Lift the non-dominant leg slightly off the bed and hold.15. Point the toes of the non-dominant foot upward.16. Flex the toes of the non-dominant foot toward the sole and then release.Each muscle group will be tensed for 10 seconds and then relaxed for 20–30 seconds . This cycle will be repeated twice for each muscle during every session. Prior to conducting the intervention, the researcher received both theoretical and practical training in progressive muscle relaxation (PMR) under the supervision of a specialist in physical medicine and lifestyle modification and holds a certification in the technique. The exercises will be conducted by the trained researcher following a standardized checklist , and all sessions will be documented in a session log, including start and end times, patient cooperation, and any adverse events or complications such as dizziness, muscle pain, or others. Any serious adverse event attributable to the study will be reported promptly to the Ethics Committee and other relevant legal authorities. Intervention 2: Control group: will receive only routine ward care and no additional interventions. 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 Considering that the process of sample collection has not yet begun and data analysis has not been conducted , it is not currently possible to make a definitive decision regarding the dissemination plan .
public Mehdi Rezvaniamin
School of Nursing and Midwifery, Mashahir Square, End of Behdasht Blvd
Zahdan Iran (Islamic Republic of) 1339698169 +98 54 3341 9085 mehdi.rezvaniamin@gmail.com Zahedan University of Medical Sciences scientific Mehdi Rezvani Amin
School of Nursing and Midwifery , Mashahir Square, End of Behdasht Blvd
Zahdan Iran (Islamic Republic of) 1339698169 +98 54 3341 9085 mehdi.rezvaniamin@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with confirmed diagnosis of ischemic stroke 20 years 80 years Both First occurrence of ischemic stroke Age range between 20 and 80 years NIHSS score < 12 Ability to read and write No history of central nervous system disorders No history of psychiatric disorders Accessibility and availability of the patient throughout the study period I63 Cerebral infarction Rehabilitation Rehabilitation Intervention group: The intervention group will undergo progressive muscle relaxation (PMR) training conducted by a trained researcher for five consecutive days. The training sessions will be delivered individually, face-to-face, once daily during the morning shift, and will last approximately 20–30 minutes at the patient’s bedside in the neurology ward. Each session involves the sequential tensing and relaxing of different muscle groups. Patients will be positioned supine, and the exercises will be performed in the following order:1. Raise the eyebrows.2. Close the eyes tightly.3. Clench the jaw and pull the corners of the mouth backward.4. Bring the chin toward the chest (without contact).5. Make a fist with the dominant hand.6. Press the dominant elbow against the body.7. Make a fist with the non-dominant hand.8. Press the non-dominant elbow against the body.9. Pull the shoulders backward, take a deep breath, and hold it.10. Contract the abdomen.11. Lift the dominant leg slightly off the bed and hold.12. Point the toes of the dominant foot upward.13. Flex the toes of the dominant foot toward the sole and then release.14. Lift the non-dominant leg slightly off the bed and hold.15. Point the toes of the non-dominant foot upward.16. Flex the toes of the non-dominant foot toward the sole and then release.Each muscle group will be tensed for 10 seconds and then relaxed for 20–30 seconds . This cycle will be repeated twice for each muscle during every session. Prior to conducting the intervention, the researcher received both theoretical and practical training in progressive muscle relaxation (PMR) under the supervision of a specialist in physical medicine and lifestyle modification and holds a certification in the technique. The exercises will be conducted by the trained researcher following a standardized checklist , and all sessions will be documented in a session log, including start and end times, patient cooperation, and any adverse events or complications such as dizziness, muscle pain, or others. Any serious adverse event attributable to the study will be reported promptly to the Ethics Committee and other relevant legal authorities. Control group: will receive only routine ward care and no additional interventions. Fatigue. Timepoint: Fatigue will be measured at baseline (prior to the initiation of the intervention), as well as on days 5 and 33 following the progressive muscle relaxation intervention. Method of measurement: Fatigue Impact Scale. Functional Ability. Timepoint: Functional Ability will be measured at baseline (prior to the initiation of the intervention), as well as on days 5 and 33 following the progressive muscle relaxation intervention. Method of measurement: Barthel and Stroke Impact Scale. Health Anxiety. Timepoint: Health Anxiety will be measured at baseline (prior to the initiation of the intervention), as well as on days 5 and 33 following the progressive muscle relaxation intervention. Method of measurement: Short Health Anxiety Inventory. Zahedan University of Medical Sciences Approved 2025-10-21 Ethic committee of Zahedan University of Medical sciences Zahedan University of Medical Sciences, Kaj Blvd., Emam Hossein Blvd zahdan Sistan-va-Balouchestan Iran (Islamic Republic of)