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IRCT20260630070019N1 IRCT 2026-07-20 Fasa University of Medical Sciences Acupressure on Anxiety, Nausea, and Vomiting in Patients Undergoing Upper Gastrointestinal Endoscopy Effect of Acupressure on Anxiety, Nausea, and Vomiting in Patients Undergoing Upper Gastrointestinal Endoscopy: A randomized clinical trial 2019-09-23 anticipated 70 Complete https://irct.ir/trial/91443 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. N/A This study examines preoperative anxiety and postoperative nausea and vomiting (PONV) in patients undergoing Esophagogastroduodenoscopy (EGD), and evaluates the effectiveness of acupressure in managing these complications.. Intervention 1: Acupressure for preoperative anxiety. Patients in this group received acupressure approximately 30 minutes before the EGD procedure in the waiting room. The Yintang point was stimulated using gentle thumb pressure applied by a trained researcher for 5 minutes. Simultaneously, the HE-7 point was stimulated using a specialized acupressure wristband secured on the patient's wrist for 20 minutes. The synergistic effect of these two points on reducing preoperative anxiety was evaluated . All interventions were performed on the right side of the body. No other interventions were provided before the procedure.Acupressure for postoperative nausea and vomiting. Following the EGD procedure, patients in this group received acupressure at the ST-36 and PC-6 points for 45 minutes. Specialized acupressure wristbands and ankle bands were secured on the right side of the body at the specified points from the beginning of the EGD procedure. The synergistic effect of these two points on reducing postoperative nausea and vomiting was evaluated . All interventions were performed on the right side of the body. Intervention 2: Control group: Patients in this group received routine care and sham (placebo) acupressure. For the anxiety assessment, a sham point with no recognized therapeutic effect (located at the beginning of the middle three fingers) was stimulated using the same gentle thumb pressure applied by the same trained researcher and the same wristband for the same duration as the intervention group.For the nausea and vomiting assessment, the control group received routine postoperative nursing care without any acupressure. Yes - There is a plan to make this available What will be shared: 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. When: The data will be available after the main study findings are published. To whom: 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. Conditions: 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. Where to obtain: Applicants should contact the corresponding authors via email to request access to the data and documents. How to obtain: 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. Comments:
public zhila ferydoni
Ebn sina square
fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 faeze.abadi@yahoo.com Fasa University of Medical Sciences scientific Faezeh Abadi
Ebn sina square
fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 faeze.abadi@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Age between 18 and 65 years No specific local problem at the acupressure application site (e.g., wound, bleeding, burn, cyst, abscess, bruising) No use of anxiolytic or antiemetic medications before the procedure by the patient or ward staff Patient is conscious and alert Not pregnant Stable hemodynamic status before endoscopy No history of psychiatric problems No history of using acupressure before an invasive procedure No history of drug or alcohol addiction No physical limitations (visual, auditory, or mental impairment) Receiving a standard and equal dose of sedative medication (2.5 mg IV Midazolam) during the procedure Undergoing a similar duration of endoscopy 18 years 65 years Both Patient's unwillingness to continue participation Cancellation of the EGD procedure during the study Gastrointestinal or intestinal obstruction Receiving sedative medication before the procedure by the patient or ward staff out of routine care Receiving antiemetic medication immediately after endoscopy upon admission to the recovery room Prevention Placebo Acupressure for preoperative anxiety. Patients in this group received acupressure approximately 30 minutes before the EGD procedure in the waiting room. The Yintang point was stimulated using gentle thumb pressure applied by a trained researcher for 5 minutes. Simultaneously, the HE-7 point was stimulated using a specialized acupressure wristband secured on the patient's wrist for 20 minutes. The synergistic effect of these two points on reducing preoperative anxiety was evaluated . All interventions were performed on the right side of the body. No other interventions were provided before the procedure.Acupressure for postoperative nausea and vomiting. Following the EGD procedure, patients in this group received acupressure at the ST-36 and PC-6 points for 45 minutes. Specialized acupressure wristbands and ankle bands were secured on the right side of the body at the specified points from the beginning of the EGD procedure. The synergistic effect of these two points on reducing postoperative nausea and vomiting was evaluated . All interventions were performed on the right side of the body. Control group: Patients in this group received routine care and sham (placebo) acupressure. For the anxiety assessment, a sham point with no recognized therapeutic effect (located at the beginning of the middle three fingers) was stimulated using the same gentle thumb pressure applied by the same trained researcher and the same wristband for the same duration as the intervention group.For the nausea and vomiting assessment, the control group received routine postoperative nursing care without any acupressure. Mean anxiety score measured by the Spielberger State-Trait Anxiety Inventory (STAI) - State Anxiety subscale. This is the primary outcome variable based on which the sample size was calculated. The score ranges from 20 to 80, with higher scores indicating greater anxiety. Timepoint: First measurement: 30 minutes before endoscopy (baseline, before intervention); Second measurement: 5 minutes after completion of acupressure intervention (post-intervention). Both measurements were taken before sedation and in the endoscopy waiting room. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI) - State Anxiety subscale, a standardized 20-item self-report questionnaire. Scores range from 20 to 80, with higher scores indicating greater anxiety. The questionnaire has a reported reliability of 79%. Severity of nausea measured by the Visual Analog Scale (VAS) following endoscopy. Nausea is defined as an unpleasant feeling of wanting to vomit. Timepoint: One hour after wearing the acupressure ankle bands and stabilization of vital signs following the endoscopy procedure. Method of measurement: Visual Analog Scale (VAS), a 10-point ruler where: 0 = no nausea, 1-3 = mild nausea, 4-6 = moderate nausea, 7-9 = severe nausea, and 10 = unbearable nausea. Patients were asked to rate their nausea on this scale. Frequency and volume of vomiting measured by counting episodes and using a graduated container. Vomiting is defined as the expulsion of gastric contents. Timepoint: One hour after wearing the acupressure ankle bands and stabilization of vital signs following the endoscopy procedure. Method of measurement: Counting the number of vomiting episodes and measuring the volume of emesis using a graduated container. Severity was categorized based on frequency: mild = less than 3 episodes, moderate = 3-5 episodes, severe = more than 5 episodes. Fasa university of medical science Approved 2019-05-23 Ethics Committee of Fasa University of Medical Sciences Ebn sina square Fasa Fars Iran (Islamic Republic of)