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IRCT20150519022320N39 IRCT 2026-08-22 Rafsanjan University of Medical Sciences effect of foot reflexology and auricular acupressure on constipation and quality of life The Effects of Auricular Acupressure and Foot Reflexology on Constipation and Quality of Life in Elderly Women Attending Comprehensive Health Service Centers in Rafsanjan, 2026 2026-09-23 anticipated 90 Recruiting https://irct.ir/trial/90623 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the samples based on the characteristics of the study, the samples were randomly divided into three intervention groups: ear acupressure, foot reflexology, and control. In this way, they were randomly selected based on numbers and a random number table and placed in three groups. N/A constipation. Intervention 1: Intervention group: The reflexology group will receive foot reflexology treatment for four weeks, three sessions per week, each session lasting fifteen minutes, each foot for seven minutes and thirty seconds. In the first session, which will be held in person, the researcher will meet with the participants and teach reflexology techniques. Key points including the large intestine, small intestine, stomach and diaphragm will be introduced, and the training will begin with a 3D foot model and a standard educational video to improve visual understanding.The researcher practically demonstrates gentle circular and longitudinal pressure and uses colored educational pamphlets with a reflexology map and step-by-step images. After training, participants perform the massage in the presence of the researcher to verify the correctness of the technique, and a standard ten-item checklist is used to assess skill. If correct, permission to perform at home is issued. In subsequent sessions, participants continue at home at least three times a week, and it is recommended that the massage be performed after a warm bath and before bedtime.For monitoring and follow-up, the researcher will set up a schedule of three weekly phone or online calls for individuals to report their experiences and progress and raise challenges. A daily logbook will be provided including date, duration, massaged points, and optional photo or short video recording of the technique for visual feedback. An instruction booklet containing key points, images, and warnings will also be given to participants. Intervention 2: Intervention group: The ear acupressure group underwent ear acupressure for ten days, five consecutive days per ear. This method was designed based on the international standards of the Reflexology Association and the Academy of Ear Acupressure and in accordance with recent authoritative research. In this intervention, Vaccaria seeds are used as pressure stimuli, which are placed on specific points on the earlobe. The selected points include the colon, rectum, San Jiao, spleen, sympathetic lung, and subcortex areas, which, based on scientific evidence, are most closely related to digestive function and the regulation of bowel movements. These points are selected with the aim of stimulating the autonomic nervous system, improving bowel movements, and reducing symptoms of constipation.Before the intervention begins, the researcher, who has received specialized training in ear acupressure, identifies the exact location of each point using standard anatomical maps of the ear. Then, with sterile forceps, he places the Vaccaria seeds on the selected points and fixes them with a special (hypoallergenic) adhesive.After the beads are placed, the researcher applies gentle pressure to each point with their index finger or thumb to provide initial stimulation. The pressure should be just enough for the participant to feel a slight warmth or tingling sensation, without causing pain, redness, or discomfort. The initial pressure is applied for about three minutes for each point. The researcher then provides a training session to the elderly participants on how to safely stimulate these points at home. The training includes a practical demonstration of the pressure method, how to identify the points by touching the bead location, adjusting the pressure intensity, and maintaining ear hygiene.To facilitate learning, a visual ear map and simple instructional videos are used. The elderly are instructed to gently press each point using their fingers for 30 to 60 seconds three times a day (morning, noon, and night). The pressure should be just enough to cause mild stimulation, and if pain, redness, or itching occurs, the stimulation should be reduced or stopped. Intervention 3: Control group: The control group is given the same conditions as the intervention groups, but no intervention is performed and they are told to continue their usual daily activities. 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 further information available
public Dr. Taybeh Mirzaei Khalilabadi
Rafsanjan, Jomhouri St., Nurse Blvd., Faculty of Nursing
rafsanjan Iran (Islamic Republic of) 7718174715 +98 34 3428 0038 t.mirzaei@roms.ac.ir Rafsanjan University of Medical Sciences scientific Dr. Taybeh Mirzaei Khalilabadi
Rafsanjan, Jomhuri St., Nurse Boulevard, Faculty of Nursing
rafsanjan Iran (Islamic Republic of) 7718174715 +98 34 3428 0038 T.Mirzaei@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Mental alertness and ability to answer questions Minimum literacy No wound at the pressure point. Diagnosis of constipation according to Rome III criteria. Having a smartphone 60 years 75 years Female Unwillingness to continue collaborating in research Incomplete completion of questionnaires Sores on the legs or ears Treating constipation with medication Death of the client travel Allergy to Vaccaria seeds Treatment - Other Treatment - Other Treatment - Other Intervention group: The reflexology group will receive foot reflexology treatment for four weeks, three sessions per week, each session lasting fifteen minutes, each foot for seven minutes and thirty seconds. In the first session, which will be held in person, the researcher will meet with the participants and teach reflexology techniques. Key points including the large intestine, small intestine, stomach and diaphragm will be introduced, and the training will begin with a 3D foot model and a standard educational video to improve visual understanding.The researcher practically demonstrates gentle circular and longitudinal pressure and uses colored educational pamphlets with a reflexology map and step-by-step images. After training, participants perform the massage in the presence of the researcher to verify the correctness of the technique, and a standard ten-item checklist is used to assess skill. If correct, permission to perform at home is issued. In subsequent sessions, participants continue at home at least three times a week, and it is recommended that the massage be performed after a warm bath and before bedtime.For monitoring and follow-up, the researcher will set up a schedule of three weekly phone or online calls for individuals to report their experiences and progress and raise challenges. A daily logbook will be provided including date, duration, massaged points, and optional photo or short video recording of the technique for visual feedback. An instruction booklet containing key points, images, and warnings will also be given to participants. Intervention group: The ear acupressure group underwent ear acupressure for ten days, five consecutive days per ear. This method was designed based on the international standards of the Reflexology Association and the Academy of Ear Acupressure and in accordance with recent authoritative research. In this intervention, Vaccaria seeds are used as pressure stimuli, which are placed on specific points on the earlobe. The selected points include the colon, rectum, San Jiao, spleen, sympathetic lung, and subcortex areas, which, based on scientific evidence, are most closely related to digestive function and the regulation of bowel movements. These points are selected with the aim of stimulating the autonomic nervous system, improving bowel movements, and reducing symptoms of constipation.Before the intervention begins, the researcher, who has received specialized training in ear acupressure, identifies the exact location of each point using standard anatomical maps of the ear. Then, with sterile forceps, he places the Vaccaria seeds on the selected points and fixes them with a special (hypoallergenic) adhesive.After the beads are placed, the researcher applies gentle pressure to each point with their index finger or thumb to provide initial stimulation. The pressure should be just enough for the participant to feel a slight warmth or tingling sensation, without causing pain, redness, or discomfort. The initial pressure is applied for about three minutes for each point. The researcher then provides a training session to the elderly participants on how to safely stimulate these points at home. The training includes a practical demonstration of the pressure method, how to identify the points by touching the bead location, adjusting the pressure intensity, and maintaining ear hygiene.To facilitate learning, a visual ear map and simple instructional videos are used. The elderly are instructed to gently press each point using their fingers for 30 to 60 seconds three times a day (morning, noon, and night). The pressure should be just enough to cause mild stimulation, and if pain, redness, or itching occurs, the stimulation should be reduced or stopped. Control group: The control group is given the same conditions as the intervention groups, but no intervention is performed and they are told to continue their usual daily activities. Constipation in older women. Timepoint: All participants completed the Rome III questionnaire and the Constipation Assessment Tool before and after the intervention. Method of measurement: ROME 3 criteria and constipation assessment scale. Quality of life of elderly women. Timepoint: All participants will complete the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire before and after the intervention. Method of measurement: Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. Rafsanjan Universityof Medical Sciences Approved 2026-06-03 Research Ethics Committee of Rafsanjan University of Medical Sciences Rafsanjan, Nurse Street, Rafsanjan School of Nursing and Midwifery rafsanjan Kerman Iran (Islamic Republic of)