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IRCT20251213068317N1 IRCT 2025-12-16 Bandare-abbas University of Medical Sciences A comparative study of the effects of showing comedy videos and foot reflexology massage on anxiety and physiological indices in patients undergoing coronary angiography A comparative study of the effects of showing comedy videos and foot reflexology massage on anxiety and physiological indices in patients undergoing coronary angiography 2025-12-29 anticipated 144 Complete https://irct.ir/trial/88104 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Each individual will be assigned to one of three intervention and control groups using the random block method, taking into account 6 blocks of 24 (random allocation list) that will be obtained in the random allocation software. The block randomization method will be used to allocate patients to the three groups.A letter (A, comedy group, B, foot reflexology group, C, control group) will be randomly assigned to each block. These letters will be written on slips of paper and placed in a container. One slip of paper will be randomly removed and the new combination will be recorded.This process will be repeated until all patients have been assigned. For each patient, the assignment to groups will be determined using sealed envelopes, and the number assigned to each patient will be consecutively assigned to maintain balance at each stage. In this way, no one, including the researchers or the patients, will know the patient's assignment to groups before the envelope is opened.This allocation concealment method will ensure fair and unbiased patient allocation, Blinding description: In this study, due to the nature of the interventions (comedy film group, foot reflexology group), blinding of participants and facilitators will not be possible. Patients will be aware of the type of intervention they are receiving, as these interventions are clearly different.However, the results analyst will not be aware of the allocation of patients to different groups to reduce bias in the analysis. The lack of blinding of participants and operators will be considered as a limitation of the study. N/A The subject of the study is not the disease. Intervention 1: Intervention group: In the comedy video category (selected from a list of films compiled by the researcher from popular and highly viewed Persian comedy video on virtual networks and excerpts from old Iranian Broadcasting Corporation comedy series that are free of scenes of violence, conflict, and profanity, while preserving human dignity and Islamic decency) The video will be shown to the audience for twenty minutes first thing in the morning before the individual enters the coronary angiography department. In this group, the video will be played via a Samsung tablet and hands-free while the subject is lying on the ward bed, with the tablet in the hands of the research sample. Intervention 2: Intervention group: Patients in the reflexology group will receive a twenty-minute massage in a cardiac aftercare room with minimal environmental stimuli (such as light and sound) and privacy for patients, by a female researcher for women and by a male researcher for men. They will be asked to lie down on a comfortable bed with their legs extended on the bed.After washing and warming their hands, the researcher will use olive oil to lubricate their hands and facilitate the reflexology intervention on the patient's feet. The intervention will begin on the left foot for ten minutes, and the massage will be performed at a slow pace, regular rhythm, and at a depth that is tolerable for the patient.The solar plexus, pituitary gland, and heart reflex points will be massaged using the thumb (which, according to reflexology principles, can reduce anxiety), without breaking contact with the skin, and then the same process will be repeated for ten minutes on the right foot. Intervention 3: Control group: In the control group, the operation will be performed without any intervention and according to the ward's routine. 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 There is no further information
public Ali Rezvani
No. 8, 4th Baharestan Street, Motahari Boulevard, Yazdanshahr, Najafabad
Najaf Abad Iran (Islamic Republic of) 8519738111 009842441427 alirezvani7030@gmail.com Bandare-abbas University of Medical Sciences scientific Shilan Azizi
Shahid Chamran Blvd، Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 13885-79166 009876-33333280-4 azizi.sh23@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patients 18 years and older Aware of time, place, and person Willingness to participate in the study and informed consent Heart patients waiting for coronary angiography First angiography experience Ability to see and hear Stable hemodynamic status before angiography Ability to communicate verbally and understand Persian language Patients with normal lower limbs (no previous varicose vein surgery, edema, open wounds, bruises, fungus, peripheral neuropathy, deep vein thrombosis, etc.) Spielberger State Anxiety Score equal to or above 43 (moderate and above) 18 years no limit Both Presence of symptoms of myocardial infarction and emergency angiography Having severe acute or chronic disorders of the liver, brain, kidney, digestive and respiratory diseases, and other severe physical illnesses Presence of a pacemaker Presence of an obstacle at the site of pressure application (wounds, skin diseases, etc.) N/A N/A N/A Intervention group: In the comedy video category (selected from a list of films compiled by the researcher from popular and highly viewed Persian comedy video on virtual networks and excerpts from old Iranian Broadcasting Corporation comedy series that are free of scenes of violence, conflict, and profanity, while preserving human dignity and Islamic decency) The video will be shown to the audience for twenty minutes first thing in the morning before the individual enters the coronary angiography department. In this group, the video will be played via a Samsung tablet and hands-free while the subject is lying on the ward bed, with the tablet in the hands of the research sample. Intervention group: Patients in the reflexology group will receive a twenty-minute massage in a cardiac aftercare room with minimal environmental stimuli (such as light and sound) and privacy for patients, by a female researcher for women and by a male researcher for men. They will be asked to lie down on a comfortable bed with their legs extended on the bed.After washing and warming their hands, the researcher will use olive oil to lubricate their hands and facilitate the reflexology intervention on the patient's feet. The intervention will begin on the left foot for ten minutes, and the massage will be performed at a slow pace, regular rhythm, and at a depth that is tolerable for the patient.The solar plexus, pituitary gland, and heart reflex points will be massaged using the thumb (which, according to reflexology principles, can reduce anxiety), without breaking contact with the skin, and then the same process will be repeated for ten minutes on the right foot. Control group: In the control group, the operation will be performed without any intervention and according to the ward's routine. Anxiety in this study refers to the score obtained from the Spielberger Anxiety Questionnaire (state section), which will be completed by the samples in two sessions. It should be noted that this questionnaire has two sections: state (situational) and trait (personality). Timepoint: Anxiety with Spielberger Anxiety Questionnaire (state section) on two occasions before the intervention and ten minutes after the intervention. Method of measurement: Spielberger Anxiety Inventory (State Section). Physiological indicators (heart rate, oxygen saturation). Timepoint: On three occasions including before, during and ten minutes after the intervention. Method of measurement: Pulse oximetry device. Bandare-abbas University of Medical Sciences Approved 2025-12-13 Ethics Committee of Hormozgan University of Medical Sciences University of Medical Sciences Campus - Vice President for Research and Technology، Beginning of Imam Hossein Blvd، Bandar Abbas Bandar Abbas Hormozgan Iran (Islamic Republic of)