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IRCT20190524043687N6 IRCT 2025-12-19 Hamedan University of Medical Sciences Investigating the Effects of Acupressure on Sleep Quality, Anxiety, and Physiological Indicators in Patients with Heart Failure Investigating the Effects of Acupressure on Sleep Quality, Anxiety, and Physiological Indicators in Patients with Heart Failure 2025-12-31 anticipated 76 Complete https://irct.ir/trial/88056 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be allocated in equal numbers to the intervention and control groups using block randomization. To ensure the unpredictability of group assignment, allocation concealment will be performed by a statistical collaborator, and the randomization sequence will remain concealed until the time of intervention. For this purpose, opaque, sealed, and sequentially numbered envelopes containing the random allocation sequence will be used. Accordingly, after generating an appropriate random sequence based on the method described above and according to the study sample size, a number of opaque envelopes will be prepared. Each randomly generated sequence will be recorded on a card, and the cards will be placed sequentially inside the envelopes. To preserve the random sequence, the envelopes will be numbered consecutively on their outer surface. Finally, the envelopes will be sealed and placed in order inside a box. At the start of participant enrollment, based on the order in which eligible participants enter the study, one envelope will be opened sequentially, and the group assignment for that participant will be revealed, Blinding description: In this study, participants, clinical caregivers, outcome assessors, and the statistical collaborator will be blinded to the allocation of patients to the intervention and control groups. The research collaborator responsible for outcome assessment will conduct evaluations without knowledge of participants’ group assignments. To maintain blinding during data analysis, study data will be provided to the statistical collaborator in a coded format (A: intervention group, B: control group), without revealing the actual group identities. To assess the effectiveness of blinding, at the end of the intervention period, participants will be asked to guess the group to which they were assigned (intervention or control). The success of blinding will then be evaluated and reported by comparing the guesses between groups using appropriate statistical tests. N/A Heart failure. Intervention 1: Intervention Group: Patients with heart failure in the intervention group will first complete questionnaires assessing sleep quality and anxiety, and their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will be measured. Then, acupressure will be applied at SP6, PC6, and HT7 points by a trained researcher. Patients will be positioned in a quiet environment with minimal noise, light, and temperature distractions, and their privacy will be maintained. The researcher will locate the precise points and gradually apply fingertip pressure in a smooth, rhythmic manner until participants report sensations of warmth, heaviness, or numbness in the targeted area without experiencing physical discomfort. This intervention will be performed twice daily, each session lasting 30 minutes, over three consecutive days. After each session, questionnaires and physiological parameters will be reassessed and recorded. To ensure the accuracy of the acupressure protocol and compliance with standard guidelines for acupressure and acupuncture research, a pilot study will be conducted prior to the main trial. Findings from this preliminary study will guide the timing of outcome measurements and finalize the intervention protocol, including session duration and frequency. Intervention 2: Control Group: Patients in this group will first complete questionnaires assessing sleep quality and anxiety. Their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will also be measured. Then, to maintain procedural consistency and blinding, they will receive gentle, superficial pressure at neutral points surrounding the main acupressure sites, following the same protocol as the intervention group. After each session, the questionnaires and physiological parameters will be reassessed and recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ali Afshari
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3838 0447 afshari777@gmail.com Hamedan University of Medical Sciences scientific Ali Afshari
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3838 0447 afshari777@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to Participate in the Study Signing of Informed Consent Form Ability to speak and understand the Persian language Diagnosed heart failure (EF < 40%), as confirmed by the treating physician 18 years no limit Both Presence of conditions such as intellectual disability, mental or behavioral disorders, hearing impairment, or speech disorders Presence of a previously diagnosed psychiatric disorder and/or sleep disorder Use of complementary therapies prior to the study Presence of addiction to alcohol, illicit drugs, or sedative medications Use of sedative or anti-anxiety medications within the past 24 hours Presence of any contraindication at the pressure application site (e.g., wounds, skin diseases, etc.) I50 Heart failure Other Other Intervention Group: Patients with heart failure in the intervention group will first complete questionnaires assessing sleep quality and anxiety, and their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will be measured. Then, acupressure will be applied at SP6, PC6, and HT7 points by a trained researcher. Patients will be positioned in a quiet environment with minimal noise, light, and temperature distractions, and their privacy will be maintained. The researcher will locate the precise points and gradually apply fingertip pressure in a smooth, rhythmic manner until participants report sensations of warmth, heaviness, or numbness in the targeted area without experiencing physical discomfort. This intervention will be performed twice daily, each session lasting 30 minutes, over three consecutive days. After each session, questionnaires and physiological parameters will be reassessed and recorded. To ensure the accuracy of the acupressure protocol and compliance with standard guidelines for acupressure and acupuncture research, a pilot study will be conducted prior to the main trial. Findings from this preliminary study will guide the timing of outcome measurements and finalize the intervention protocol, including session duration and frequency. Control Group: Patients in this group will first complete questionnaires assessing sleep quality and anxiety. Their physiological parameters, including systolic and diastolic blood pressure, heart rate, respiratory rate, and arterial oxygen saturation, will also be measured. Then, to maintain procedural consistency and blinding, they will receive gentle, superficial pressure at neutral points surrounding the main acupressure sites, following the same protocol as the intervention group. After each session, the questionnaires and physiological parameters will be reassessed and recorded. Sleep Quality. Timepoint: Before the start of the study and on the second, third, and fourth days of hospitalization. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Anxiety. Timepoint: Spielberger Anxiety Questionnaire. Method of measurement: Before, immediately after, and 30 minutes after the daily intervention. Arterial oxygen saturation. Timepoint: Before, immediately after, and 30 minutes after the daily intervention. Method of measurement: Pulse oximetry. Systolic blood pressure. Timepoint: Before, immediately after, and 30 minutes after the intervention. Method of measurement: Digital sphygmomanometer. Diastolic blood pressure. Timepoint: Before, immediately after, and 30 minutes after the intervention. Method of measurement: Digital sphygmomanometer. Heart rate. Timepoint: Before, immediately after, and 30 minutes after the intervention. Method of measurement: Pulse oximetry. Hamedan University of Medical Sciences Approved 2025-12-13 Research Ethical Committee of Hamadan University of Medical Sciences Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)