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

Determining and comparing the effects of touch therapy and virtual reality on pain intensity, anxiety level, and satisfaction in patients requiring suturing presenting to the emergency department

This is a randomized controlled clinical trial, single-blinded with three parallel groups: therapeutic touch, virtual reality, and control group. Sampling was done by convenience method and by assigning individuals to groups based on random blocks of 9 generated by an online system, on 81 patients.

Statistical blinding. Sampling is by convenience method and 81 patients are randomly assigned based on blocks of 9 into three equal groups. The first group receives a therapeutic touch intervention by a trained companion, which includes standard hand massage techniques during the suturing process. The second group uses a virtual reality headset with naturalistic content and relaxing music. The control group receives only routine emergency care. Data are collected using standard questionnaires including the Visual Analogue Scale of Pain, the Spielberger State-Trait Anxiety Inventory , and the Satisfaction Scale before and after the intervention.

Inclusion: Age over 18, consciousness, tear greater than 2 cm, no pain medication, no tendon rupture or mental disorder, specific suture. Exclusion: Disability, self-harm, multiple tears, addiction, dementia, seizures, head/face laceration, hand deformity.

Control Group: This group receives routine emergency care. Touch Therapy Group: Touch therapy is taught to the patient's companion to be performed during suturing. Virtual Reality Group: Patients use VR headset. Relaxing content is played 5 minutes before anesthesia and during suturing.

Pain intensity, anxiety level, and patient satisfaction

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.

No further information is available.

Individual participant data, including pain scores (VAS), anxiety scores (STAI), and satisfaction scores (VAS‑sat), along with baseline demographic characteristics, will be made available upon reasonable request and with the approval of the Research Ethics Committee of Kerman University of Medical Sciences. Data will be shared in a secure, anonymized format (SPSS or Excel file) for non‑commercial research purposes only, and recipients will be required to sign a confidentiality agreement.

Access to individual participant data will begin 6 months after the publication of the main study results and will remain available for a period of 5 years. The publication date will subsequently be announced through reputable scientific databases.

Access to the data and study documents will be granted solely to researchers affiliated with academic institutions, research centers, and recognized scientific organizations that have obtained approval from the Research Ethics Committee of Kerman University of Medical Sciences. Requests submitted by individuals working in industry or commercial sectors will not be accepted unless they are collaborating with an academic institution. All applicants will be required to submit a valid research proposal and sign a confidentiality and non‑commercial use agreement prior to receiving any data.

The data provided may only be used for analyses specifically approved by the Research Ethics Committee of Kerman University of Medical Sciences, and any analysis beyond the approved framework is strictly prohibited. Use of the data is permitted solely for non‑commercial research purposes, and any commercial exploitation of the data or documents is expressly forbidden. All analyses conducted on the data must cite the source (this study) in any scientific publications resulting from the work. The data and documents provided may not be redistributed to third parties and will be made available only to the requesting researcher. Applicants are required to share the results of their analyses with the principal investigator's team. Any publication of results based on these data requires written approval from the principal investigator's team.

Applicants may submit their written request for access to the data and documents of this study through one of the following channels: First Priority (Email): Email Address: r_Mhdipour@kmu.ac.ir (Responses will be provided as soon as possible, within a maximum of 72 hours) Second Priority (Postal Correspondence): Address: Department of Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh-e Alavi, Kerman, Iran Postal Code: 7616913555 Telephone: +98 34 3132 5194 Third Priority (Telephone Contact): Telephone Number: +98 34 3132 5194 (Office hours: 8:00 AM to 2:00 PM) Contact Person: Dr. Roghayeh Mehdipour Raberi (Associate Professor, Department of Nursing, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences) Email: r_Mhdipour@kmu.ac.ir All requests must include the applicant's full name, institutional affiliation, a brief description of the purpose of the data request, and the proposed research plan. Requests will be reviewed within a maximum of 2 working weeks, and the outcome will be communicated to the applicant via email.

Applicants requesting access to the data and documents of this study are required to follow the steps outlined below: Step 1: Submission of Written Request The applicant must submit a written request via email (r_Mhdipour@kmu.ac.ir). The request must include the following: Full name, institutional affiliation, and valid identification documents Comprehensive description of the purpose of the data request and research objectives Proposed research plan including research questions, analysis methods, and timeline Commitment to maintain confidentiality and non‑commercial use of the data Step 2: Initial Review by the Principal Investigator's Team The received request is reviewed by the principal investigator's team. This review includes scientific evaluation of the proposed plan, alignment with the study objectives, and verification of the applicant's academic qualifications. If necessary, the principal investigator may contact the applicant for further clarification. Step 3: Referral to the Research Ethics Committee Following initial approval by the principal investigator's team, the request is referred to the Research Ethics Committee of Kerman University of Medical Sciences. The Ethics Committee reviews the ethical aspects of the request, including data confidentiality and protection of participant rights. Step 4: Signing the Data Access Agreement After receiving Ethics Committee approval, the applicant is required to review and sign a Data Access Agreement. This agreement includes commitments to non‑commercial use, non‑redistribution of data to third parties, proper citation of the source in publications, and provision of results to the principal investigator's team. Step 5: Data Delivery Upon signing the agreement, the requested data will be provided to the applicant in a secure, anonymized format (SPSS or Excel file) via email or a secure download link. Timeline: The entire process from request receipt to data delivery will take a maximum of 4 working weeks. Applicants can expect to receive the initial review outcome within 2 working weeks of submission, and, if approved, the data will be delivered within a further 2 working weeks after signing the agreement.