Effect of Acupressure on Anxiety, Nausea, and Vomiting in Patients Undergoing Upper Gastrointestinal Endoscopy: A randomized clinical trial

The effect of acupressure on preoperative anxiety and postoperative nausea and vomiting in patients undergoing upper gastrointestinal endoscopy.

A single-blind, parallel-group, randomized controlled clinical trial with two intervention groups and one control group.Total sample size was 70 participants.

The study was conducted in 2019 in the endoscopy unit of Vali-e-Asr Specialized Teaching Hospital, affiliated with Fasa University of Medical Sciences, Fars Province, Iran. A trained researcher performed acupressure on the intervention groups. The control group received sham acupressure (anxiety assessment) and routine care (nausea/vomiting assessment). Participants in the control group were blinded to the sham intervention's non-therapeutic nature. The outcome assessor and data analyst were also blinded to group allocation.

Inclusion Criteria: Age 18-65 years; stable hemodynamic status; no skin lesions at acupressure sites,... Exclusion Criteria: Unwillingness to continue participation; cancellation of EGD procedure during the study; gastrointestinal obstruction, ...

Intervention Group 1 (Anxiety): Acupressure at Yintang (5 min, thumb pressure) and HE-7 (20 min, wristband) points, 30 minutes before EGD. Intervention Group 2 (Nausea/Vomiting): Acupressure at ST-36 and PC-6 points (45 min, ankle bands and thumb pressure) from the start of EGD. Control Group: Received routine care and sham acupressure (non-specific point) for anxiety assessment; routine care only for nausea/vomiting assessment. Participants were blinded to sham intervention.

(1) Mean anxiety score measured by Spielberger State-Trait Anxiety Inventory (STAI), (2) Nausea severity measured by Visual Analog Scale (VAS), (3) Vomiting frequency and volume measured by counting episodes and graduated container.

This study employed a block randomization method with a block size of four to allocate participants to either the intervention or control group. The unit of randomization was the individual participant. To ensure comparability between groups, participants were stratified and matched based on two key baseline characteristics: history of previous endoscopy (yes/no) and age category (below 30 years or 30 years and above). The randomization sequence was generated using a computer random number generator by an independent statistician who was not involved in participant recruitment, intervention delivery, or outcome assessment. Allocation concealment was rigorously maintained using sequentially numbered, opaque, sealed envelopes. The envelopes were prepared by the independent statistician and were opened sequentially only immediately before the intervention by the researcher who administered the acupressure, ensuring that neither the participants nor the outcome assessor were aware of the group assignments until the moment of intervention. In cases where participants were excluded from the study after randomization, new eligible participants were recruited and allocated to the appropriate groups using the same block randomization method to maintain the intended sample size and balance between groups.

This was a single-blind study. The outcome assessor was blinded to the group allocation of participants throughout the study. Participants in the intervention group received active acupressure at specific acupoints (Yintang and HE-7 for anxiety; ST-36 and PC-6 for nausea and vomiting), while participants in the control group received acupressure at a sham (placebo) point that had no therapeutic effect. The control group participants were not informed that they were receiving a sham intervention and were unaware of its non-therapeutic nature, thus ensuring blinding of the participants. The researcher who performed the acupressure and the clinical staff were aware of the group assignments due to the nature of the intervention; however, all outcome measurements were collected by a trained research assistant who was blinded to the group allocation. Additionally, the statistical analysis was performed by an independent statistician who was not involved in the intervention.

All collected de-identified individual participant data (IPD) for the outcome measures, including anxiety scores (STAI), nausea severity (VAS), vomiting frequency and volume, and demographic information (age, gender, education, history of endoscopy, BMI, vital signs), as well as the study protocol and statistical analysis plan.

The data will be available after the main study findings are published.

De-identified IPD and supporting documents will be available to researchers working in academic and scientific institutions (universities, research centers, and hospitals) who submit a valid research proposal. Researchers from commercial organizations (industry) may also apply, but their requests will be reviewed on a case-by-case basis for scientific validity and potential conflicts of interest.

Requests for data access will be reviewed by the corresponding authors (Dr. Zhila Fereidouni and Faezeh Abadi). Criteria for approval include: (1) submission of a methodologically sound research proposal with clear objectives, (2) approval from the applicant's institutional ethics committee, (3) agreement to use the data solely for the proposed analyses, (4) commitment to not attempt to re-identify participants, (5) acknowledgment of the original study in any publications, and (6) agreement to share any resulting publications with the study team. Data will only be shared for non-commercial, scientific research purposes. The review process typically takes 2-4 weeks.

Applicants should contact the corresponding authors via email to request access to the data and documents.

The process for requesting data access involves the following steps: Submission (Week 1): The applicant submits a formal request via email to the corresponding authors, including their institutional affiliation, research proposal with clear objectives, and proof of ethics approval. Review (Weeks 1-3): The corresponding authors review the request for scientific validity, methodological soundness, and absence of conflicts of interest. They may request additional information or clarification during this period. Decision (Week 3-4): The applicant is notified of the decision. If approved, a Data Sharing Agreement (DSA) is provided for signature, outlining terms of use, confidentiality, and publication requirements. Data Preparation and Transfer (Week 4-5): Once the signed DSA is returned, the de-identified dataset and supporting documents (study protocol, statistical analysis plan, data dictionary) are prepared and shared via a secure file transfer method (e.g., encrypted email, institutional data repository). The entire process from initial request to data receipt is estimated to take 4-6 weeks, depending on the completeness of the initial application and the responsiveness of the applicant.