A Comparative Study of the Effects of Ice Massage and Shiatsu Applied to the Hegu Point on Pain and Anxiety Associated with Arteriovenous Fistula Needle Insertion in Hemodialysis Patients: A Clinical Trial

A Comparative Study of the Effects of Ice Massage and Shiatsu at the Hegu Point on Pain Intensity and Anxiety Caused by Needle Insertion into the Fistula in Patients Undergoing Hemodialysis

This study is a three‑arm randomized parallel clinical trial (1:1:1) in which 72 patients are allocated to Shiatsu massage, ice massage, and control groups using stratified permuted block randomization.

This clinical trial is conducted in the hemodialysis unit of Towhid Hospital, Sanandaj. Owing to the nature of the interventions (Shiatsu massage and ice application at the Hegu point), full blinding is not feasible; therefore, participants and intervention providers are aware of the treatment type, while to minimize potential bias, the outcome assessor and data analyst remain blinded to group allocation.

Patients aged 18–65 years undergoing hemodialysis with a stable arteriovenous fistula, without substance abuse, use of medications affecting pain or anxiety, or disorders of pain perception, will be enrolled in the study and will be withdrawn in the event of clinical instability or increased risk of fistula thrombosis.

Shiatsu Group: Vertical thumb pressure is applied at the LI‑4 point on the non‑fistula hand with an intensity of 2–3 kg/cm² for 40 minutes (four 5‑minute cycles with 2‑minute rest intervals). Ice Massage Group: A cold gel pack (0 to −4°C) is applied to the LI‑4 point for a duration equivalent to that of the Shiatsu group. Control Group: A sham intervention is administered at the TE5 point on the posterior forearm in the form of light pressure, with a contact duration comparable to that of the intervention groups.

The level of pain and anxiety associated with arteriovenous fistula needle insertion in patients undergoing hemodialysis.

To control for confounding variables and ensure balance across the intervention groups, a stratified block randomization method will be employed. The unit of randomization is the individual, with each participant independently assigned to a study group. Participants will first be stratified based on four primary variables: age (<50 vs. ≥50 years), sex (male vs. female), fistula type (radial vs. brachial), and duration of fistula use (<1 year vs. ≥1 year). The combination of these variables results in 16 distinct strata. For each stratum, random blocks of size six will be utilized, ensuring that within each block, two participants are allocated to each of the three study arms: the Shiatsu massage group, the ice pack group, and the control group. The allocation sequences will be generated using Random Allocation Software (version 2.0). To minimize bias, these sequences will be produced by an independent individual who is not involved in the executive team, data collection, or intervention delivery. To ensure allocation concealment, the generated sequences will be placed in opaque, sequentially numbered, and sealed envelopes, which will be stored in a secure location. Following the screening process and the acquisition of informed consent from eligible patients, their demographic and clinical data will be recorded. Each participant will then be assigned to the appropriate stratum based on their characteristics. Subsequently, the corresponding envelope for that stratum will be opened in numerical order, and the participant will be assigned to a study group according to the predetermined sequence

In this clinical trial, due to the nature of the interventions under investigation (Shiatsu massage and application of an ice pack at the Hegu point), complete blinding of participants and intervention providers is not feasible. Therefore, participating patients and healthcare personnel responsible for delivering the intervention will be aware of the type of intervention administered. However, to minimize observer and analytical bias, specific measures have been implemented to ensure blinding at the stages of outcome assessment and data analysis. Accordingly, the outcome assessor, who is responsible for recording and collecting data related to pain intensity and anxiety levels, will be blinded to the participants’ group allocation. The outcome assessor will not be involved in the randomization process or in the implementation of the interventions and will complete the measurement instruments solely based on participants’ identification codes. In addition, the data analyst will also be blinded to group allocation. The randomization process and assignment of participants to study groups will be performed by a researcher who is not involved in outcome assessment or data analysis. Consequently, in this study, blinding is implemented at the levels of outcome assessment and data analysis in order to reduce the risk of bias in the recording and interpretation of the results.

Title of Data/Documents: Clinical Trial Dataset on Pain and Anxiety Measures During Arteriovenous Fistula Needle Insertion in Hemodialysis Patients: Effects of Shiatsu and Ice Massage Interventions Details: This dataset comprises anonymized individual participant data collected during a randomized clinical trial investigating the effects of Shiatsu massage, ice massage, and a control intervention on pain intensity and anxiety levels associated with arteriovenous fistula (AVF) needle insertion in hemodialysis patients. The data include demographic characteristics, clinical inclusion/exclusion criteria, randomization strata, intervention adherence, and primary (pain intensity measured by Numeric Rating Scale) and secondary outcomes (state anxiety assessed by the Spielberger State Anxiety Inventory). All personal identifiers have been removed or masked according to established de-identification protocols to ensure participants’ confidentiality and privacy. Therefore, the full dataset is potentially shareable with authorized researchers for secondary analyses following appropriate data use agreements. Certain sensitive variables related to patient comorbidities and medication history are included but anonymized. Access to data will be granted under controlled conditions to protect patient confidentiality. If data sharing is limited to specific variables (e.g., only primary outcomes or summary data), please specify accordingly.

Data will be available 6 months post-publication.

The study data and documents will be accessible to both of the following groups: A) Academic researchers: University faculty members, Research institute scientists, Graduate students (with supervisor approval).

Access to de-identified data and study documents is subject to the following requirements: a) General Conditions: Submission of formal request including research objectives, analysis plan and timeline, Approval by the ethics committee of requester's institution, Signed limited data use agreement. b) Analytical Restrictions: Any statistical analysis is permitted provided it doesn't enable indirect identification, Subgroup comparisons require minimum 10 cases per group, Machine learning applications need separate approval. c) Usage Permissions: Permitted for academic research and therapeutic protocol development, Commercial use requires separate licensing agreement, Educational materials may be redistributed with proper attribution. d) Oversight Mechanisms: Mandatory progress reports every 6 months, Periodic audits by independent data monitor, Data deletion commitment after project completion.

Applicants can request data and study documentation by sending an email to the following address: golnaz.azami64@gmail.com

Request Procedure: Formal Request Submission: Complete request form (if applicable), Email to golnaz.azami64@gmail.com with clear subject. Attach: -Research proposal, -Ethics approval, -Affiliation documents. *Initial Review (3-5 business days): -Document completeness check, -Research objectives alignment assessment, *Technical Evaluation (7-10 business days): -Analysis plan review by technical team, -Access level determination, -De-identified data preparation. *Agreement Finalization (5-7 business days): -NDA signing, -Usage terms confirmation. -Cost determination (if applicable). *Data Delivery (2-3 business days post-agreement): -Secure platform transfer, -User guide provision, -Analysis restrictions specification, Total Processing Time: 15-25 business days (depending on request complexity).