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IRCT20260627069963N1 IRCT 2026-07-04 Kerman University of Medical Sciences The effect of therapeutic touch and virtual reality on pain intensity, anxiety level, and satisfaction in patients requiring sutures. Comparison of the Effect of Touch Therapy and Virtual Reality on Pain Intensity, Anxiety Level, and Satisfaction in Patients Requiring Sutures Referred to the Emergency Department 2026-06-29 anticipated 81 Complete https://irct.ir/trial/91235 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: In this study, blinding of participants is not feasible due to the nature of the interventions (touch therapy and virtual reality). Touch therapy requires the patient's awareness of physical contact, and virtual reality is clearly distinguishable; moreover, the use of a sham intervention (e.g., neutral content) would not completely mislead the patient. To mitigate assessment bias, statistical blinding will be employed, whereby the data analyst remains unaware of group allocation, allowing the results to be examined without prejudice. N/A Patients Requiring Sutures. Intervention 1: Control group: This group receives routine emergency care. In standard care, the emergency physician, after local anesthesia with 2% lidocaine (based on wound size and patient weight) and wound examination, performs wound closure in a minor procedure room. Patients have the opportunity to request additional local anesthesia during the procedure. All simple laceration suturing will be performed by the emergency physician. A simple laceration refers to a skin tear that does not involve nerves, tendons, arteries, veins, or bones. Before suturing and intervention, patients are placed in an appropriate position. To ensure maximum consistency of conditions, all patients will be placed in a supine position under suitable conditions before and after the intervention. Routine care provided to all patients includes the following: initially, the wound and the area to be sutured are irrigated with 0.9% normal saline by an experienced emergency operating room nurse. The emergency physician's hands are washed using the proper technique and sterile gloves are worn. All required equipment, including syringes, local anesthetic, suture needles and threads, and suture sets, are prepared and placed sterilely on the tray. Lidocaine 2% without epinephrine (based on wound size and patient weight, with a maximum dose of 4.5 cc/kg) is used for anesthesia of the suture site. The syringe is filled using a sterile technique, and a 25G or 27G needle is selected according to the injection site. For anesthetic injection, the emergency physician first disinfects the skin of the target area again with Hexaspet or alcohol antiseptic solution, then the pre-filled syringe is gently inserted into the dermal area at a 10-15 degree angle, and lidocaine is injected gradually. Injection is performed in a parallel manner around the wound and its edges to ensure complete anesthesia of the entire area. After injection, 3-5 minutes are allowed for the anesthetic to take full effect, then the wound is examined, and if suturing is required, it is performed by an experienced emergency physician. For simple interrupted sutures, a sterile reverse-cutting curved needle with 4-0 nylon suture material is selected. The needle is inserted into the skin at an appropriate depth and angle according to the suture site, maintaining a distance of approximately 3-5 mm from the wound edge. The needle is passed in a curved manner from one side of the wound and exits from the other side at the same distance from the wound edge (ensuring equal depth of entry and exit). The suture is then pulled to approximate the wound edges. Finally, simple knots are tied (5-6 simple knots) and the suture ends are cut to an appropriate length. This process is repeated for each suture individually. For vertical mattress sutures, the needle is inserted approximately 4-6 mm from the wound edge and exits from the opposite side at the same distance from the wound edge. The needle is then reinserted approximately 1-2 mm from the wound edge and exits from the opposite side at the same distance. The suture is pulled to approximate the wound edges, and then 4-6 simple knots are tied and secured. Finally, the suture ends are cut to an appropriate length. This process is repeated for each suture individually. Throughout the study, every effort will be made to ensure that all procedures are performed by the same physician and the same nurse. Intervention 2: Intervention group: First Intervention Group – Touch Therapy by Patient's Companion Among the patient's companions, the one who has the closest relationship and attachment to the patient and has no mental health issues will be selected if willing to participate in the intervention. A 3-minute instructional video is shown to the companion, followed by in-person practical training. The training content includes: 1) introduction to the basic principles of touch therapy and its benefits in reducing pain and anxiety; 2) training in standard touch therapy techniques; 3) emphasis on avoiding direct pressure on the wound or painful areas; and 4) observance of ethical principles (respecting the patient's privacy and obtaining verbal consent during performance).After training completion, the companion sits beside the patient's bed and a calm environment is established (reducing light and ambient noise when possible). The patient is asked to close their eyes and practice deep breathing. Then, the companion gently takes the patient's hands and performs touch therapy during suturing with gentle, rhythmic movements (such as stroking the back of the hand or massaging the palm) according to the following steps: Hand Massage Steps: First Touch (Gentle Rhythmic Pressure): Using the fingertips, gentle rhythmic pressure is applied to the thenar eminence, the base of the index finger, the webbing between fingers, and the fleshy part of the palm (palmar surface). Second Touch (Compressive-Rotatory Touch): Using the thumb and index finger eminences, compressive touch with a twisting motion (similar to gentle squeezing and kneading) is applied from the base to the tip of each of the patient's fingers. Third Touch (Circular Massage): While the patient's palm is supported by the companion's palm, the back of the patient's hand and fingers are massaged in a circular motion with the other palm. The researcher indirectly monitors the correct execution of the touch from an appropriate distance, and in case of errors, the intervention is corrected or stopped. Intervention 3: Intervention group: Second Intervention Group – Virtual Reality VRG (virtual reality glasses) are devices that work with compatible smartphones. They can be used to watch videos taken at a 360‑degree angle, and any type of wired headphones can be connected to the audio output. Observing relaxing images along with soothing music through VRG during invasive procedures such as suturing allows patients to embark on an imaginary journey that distances them from the clinic where they are surrounded by medical equipment and leads them to a calmer environment. It is believed that the use of VRG increases the secretion of endorphins and oxytocin while reducing adrenaline levels, thus inducing physical relaxation. This technology can be used as a non‑invasive and effective method for pain relief. This approach was selected because studies using VRG have demonstrated that it is an efficient method for pain management. A video depicting a natural environment along with music featuring nature sounds is shown to patients in the VRG intervention group for 5 minutes prior to anesthetic injection and during wound repair by suturing. Headphones are used to listen to recorded music that plays nature sounds. The glasses are placed on the patient's eyes before suturing begins and are not removed during wound repair. The aim is for patients to observe nature more effectively and listen to its sounds, allowing them to focus on the images and sounds and distract themselves from the stress of the current environment. The same video was shown to each patient, and the glasses were disinfected after each use. Regarding the equipment used, a VR headset with high resolution and a wide field of view (at least 100 degrees) was used, and the designed content includes relaxing environments such as seashore, forest, and green spaces with nature sound effects. The patient will be positioned in a semi‑recumbent or supine position on the emergency bed. Ambient lighting will be adjusted and distracting noises minimized. The use of the headset will be explained to the patient, and the patient will also be assured that if they experience dizziness or discomfort, they may remove the device. Regarding the intervention protocol, five minutes before suturing begins, the headset is placed on the patient's head and the necessary adjustments are made for comfort. The patient is immersed in the virtual environment for the duration of the suturing, noting that the VR content is 10 minutes long and is replayed if needed. During the intervention, the researcher remains beside the patient to assist if necessary. After the intervention is completed, the headset is removed from the patient's head, and the patient is then given 2‑3 minutes to re‑adapt to the real environment. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available.
public Dr. Roghayeh Mehdipour Rabori
Haft Bagh-e Alavi Axis (Beginning), Kerman University of Medical Sciences Campus, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5194 r_Mhdipour@kmu.ac.ir Kerman University of Medical Sciences scientific Dr. Roghayeh Mehdipour Rabori
Haft Bagh-e Alavi Axis (Beginning), Kerman University of Medical Sciences Campus, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5194 r_Mhdipour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) At least 18 years of age Alert and oriented to time, place, and person Patients with lacerations at least 2 cm in length that require suturing for wound closure No use of anxiolytics or analgesics within 12 hours prior to the study No tendon or ligament rupture No severe psychiatric disorders (e.g., psychotic disorders, schizophrenia, post‑traumatic stress disorder, major depressive disorder, etc.) Patients whose suturing is performed using 4‑0 nylon suture with a reverse‑cutting needle. The suturing technique used is either simple interrupted or vertical mattress 18 years no limit Both Visual, hearing, speech, or physical disability and paralysis Having a rheumatologic disease and undergoing medical treatment Lacerations resulting from self‑harm Multiple lacerations and concurrent injury to other organs Opioid addiction Patients with a history of senile dementia, seizure disorder, motion sickness, or any condition that affects tactile perception. Patients with lacerations on the head or face that would interfere with placement of the virtual reality headset. Patients who had injury or infection above the neck Erythema, edema, fracture, pain, or abnormality in the hands, as well as other conditions affecting the hands (e.g., phlebitis, diabetes mellitus, neurological disorders) Patients who have received massage or other relaxation interventions (e.g., music therapy) within the past week Other Other Other Control group: This group receives routine emergency care. In standard care, the emergency physician, after local anesthesia with 2% lidocaine (based on wound size and patient weight) and wound examination, performs wound closure in a minor procedure room. Patients have the opportunity to request additional local anesthesia during the procedure. All simple laceration suturing will be performed by the emergency physician. A simple laceration refers to a skin tear that does not involve nerves, tendons, arteries, veins, or bones. Before suturing and intervention, patients are placed in an appropriate position. To ensure maximum consistency of conditions, all patients will be placed in a supine position under suitable conditions before and after the intervention. Routine care provided to all patients includes the following: initially, the wound and the area to be sutured are irrigated with 0.9% normal saline by an experienced emergency operating room nurse. The emergency physician's hands are washed using the proper technique and sterile gloves are worn. All required equipment, including syringes, local anesthetic, suture needles and threads, and suture sets, are prepared and placed sterilely on the tray. Lidocaine 2% without epinephrine (based on wound size and patient weight, with a maximum dose of 4.5 cc/kg) is used for anesthesia of the suture site. The syringe is filled using a sterile technique, and a 25G or 27G needle is selected according to the injection site. For anesthetic injection, the emergency physician first disinfects the skin of the target area again with Hexaspet or alcohol antiseptic solution, then the pre-filled syringe is gently inserted into the dermal area at a 10-15 degree angle, and lidocaine is injected gradually. Injection is performed in a parallel manner around the wound and its edges to ensure complete anesthesia of the entire area. After injection, 3-5 minutes are allowed for the anesthetic to take full effect, then the wound is examined, and if suturing is required, it is performed by an experienced emergency physician. For simple interrupted sutures, a sterile reverse-cutting curved needle with 4-0 nylon suture material is selected. The needle is inserted into the skin at an appropriate depth and angle according to the suture site, maintaining a distance of approximately 3-5 mm from the wound edge. The needle is passed in a curved manner from one side of the wound and exits from the other side at the same distance from the wound edge (ensuring equal depth of entry and exit). The suture is then pulled to approximate the wound edges. Finally, simple knots are tied (5-6 simple knots) and the suture ends are cut to an appropriate length. This process is repeated for each suture individually. For vertical mattress sutures, the needle is inserted approximately 4-6 mm from the wound edge and exits from the opposite side at the same distance from the wound edge. The needle is then reinserted approximately 1-2 mm from the wound edge and exits from the opposite side at the same distance. The suture is pulled to approximate the wound edges, and then 4-6 simple knots are tied and secured. Finally, the suture ends are cut to an appropriate length. This process is repeated for each suture individually. Throughout the study, every effort will be made to ensure that all procedures are performed by the same physician and the same nurse. Intervention group: First Intervention Group – Touch Therapy by Patient's Companion Among the patient's companions, the one who has the closest relationship and attachment to the patient and has no mental health issues will be selected if willing to participate in the intervention. A 3-minute instructional video is shown to the companion, followed by in-person practical training. The training content includes: 1) introduction to the basic principles of touch therapy and its benefits in reducing pain and anxiety; 2) training in standard touch therapy techniques; 3) emphasis on avoiding direct pressure on the wound or painful areas; and 4) observance of ethical principles (respecting the patient's privacy and obtaining verbal consent during performance).After training completion, the companion sits beside the patient's bed and a calm environment is established (reducing light and ambient noise when possible). The patient is asked to close their eyes and practice deep breathing. Then, the companion gently takes the patient's hands and performs touch therapy during suturing with gentle, rhythmic movements (such as stroking the back of the hand or massaging the palm) according to the following steps: Hand Massage Steps: First Touch (Gentle Rhythmic Pressure): Using the fingertips, gentle rhythmic pressure is applied to the thenar eminence, the base of the index finger, the webbing between fingers, and the fleshy part of the palm (palmar surface). Second Touch (Compressive-Rotatory Touch): Using the thumb and index finger eminences, compressive touch with a twisting motion (similar to gentle squeezing and kneading) is applied from the base to the tip of each of the patient's fingers. Third Touch (Circular Massage): While the patient's palm is supported by the companion's palm, the back of the patient's hand and fingers are massaged in a circular motion with the other palm. The researcher indirectly monitors the correct execution of the touch from an appropriate distance, and in case of errors, the intervention is corrected or stopped Intervention group: Second Intervention Group – Virtual Reality VRG (virtual reality glasses) are devices that work with compatible smartphones. They can be used to watch videos taken at a 360‑degree angle, and any type of wired headphones can be connected to the audio output. Observing relaxing images along with soothing music through VRG during invasive procedures such as suturing allows patients to embark on an imaginary journey that distances them from the clinic where they are surrounded by medical equipment and leads them to a calmer environment. It is believed that the use of VRG increases the secretion of endorphins and oxytocin while reducing adrenaline levels, thus inducing physical relaxation. This technology can be used as a non‑invasive and effective method for pain relief. This approach was selected because studies using VRG have demonstrated that it is an efficient method for pain management. A video depicting a natural environment along with music featuring nature sounds is shown to patients in the VRG intervention group for 5 minutes prior to anesthetic injection and during wound repair by suturing. Headphones are used to listen to recorded music that plays nature sounds. The glasses are placed on the patient's eyes before suturing begins and are not removed during wound repair. The aim is for patients to observe nature more effectively and listen to its sounds, allowing them to focus on the images and sounds and distract themselves from the stress of the current environment. The same video was shown to each patient, and the glasses were disinfected after each use. Regarding the equipment used, a VR headset with high resolution and a wide field of view (at least 100 degrees) was used, and the designed content includes relaxing environments such as seashore, forest, and green spaces with nature sound effects. The patient will be positioned in a semi‑recumbent or supine position on the emergency bed. Ambient lighting will be adjusted and distracting noises minimized. The use of the headset will be explained to the patient, and the patient will also be assured that if they experience dizziness or discomfort, they may remove the device. Regarding the intervention protocol, five minutes before suturing begins, the headset is placed on the patient's head and the necessary adjustments are made for comfort. The patient is immersed in the virtual environment for the duration of the suturing, noting that the VR content is 10 minutes long and is replayed if needed. During the intervention, the researcher remains beside the patient to assist if necessary. After the intervention is completed, the headset is removed from the patient's head, and the patient is then given 2‑3 minutes to re‑adapt to the real environment. Pain intensity. Timepoint: The questionnaires are administered by the researcher via direct questioning of the patient, five minutes before local anesthesia and suturing, and are completed once more after the suturing procedure. Method of measurement: Visual analog scale. Anxiety level. Timepoint: The questionnaires are administered by the researcher via direct questioning of the patient, five minutes before local anesthesia and suturing, and are completed once more after the suturing procedure. Method of measurement: Spielberg State-Trait Anxiety Inventory. Satisfaction. Timepoint: After the suturing is completed. Method of measurement: Visual Analog Scale for Satisfaction. Kerman University of Medical Sciences Approved 2026-01-11 Ethics committee of Kerman University of Medical Sciences Aria Building, 7th Alley, Imam Hassan Boulevard, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)