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IRCT20150317021497N8 IRCT 2022-10-09 Rafsanjan University of Medical Sciences Comparison of the effectiveness of music therapy and hand-holding on stress and pain of patients undergoing endoscopy Comparison of the effectiveness of music therapy and hand-holding on perceived stress and pain of patients undergoing endoscopy referring to Rafsanjan Gastroenterology Clinic 2022-10-23 anticipated 32 Complete https://irct.ir/trial/66143 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using computer software (Random Allocation), patients are placed in three groups of music therapy, hand-holding, or control through four blocks with an allocation ratio of 1:1:1. During the endoscopy procedure, the music therapy group will listen to nature music through headphones. The hand-holding group will have their hand in their companion's hand during the endoscopy process, and the control group will not receive any of these two interventions. The random allocation sequence will be generated by a person not involved in the research. Both groups will receive routine treatments. N/A Condition 1: Peptic Ulcer. Condition 2: Dyspepsia. Condition 3: Duodenal ulcer. Condition 4: Gastrointestinal hemorrhage. Intervention 1: The first intervention group: listening to a nature background music through headphones during endoscopy process. Intervention 2: The second intervention group: partner's hand holding during the endoscopy process. Intervention 3: Control group: without any intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Commitment to the principle of fiduciary Where to obtain: Sending an official letter to the Research Vice-Chancellor of Rafsanjan University of Medical Sciences How to obtain: After the approval of the research vice-chancellor of Rafsanjan University of Medical Sciences, the data will be provided to the applicant. Comments:
public Vahid Mirzaee
Ali Ibn Abi-talib hospital, Imam Ali Blvd
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0000 vah_mirzaee@yahoo.com Rafsanjan University of Medical Sciences scientific Vahid Mirzaee
Ali Ibn Abi-Talib Hospital, Imam Ali Blvd
Rafsanjan Iran (Islamic Republic of) 7717937555 +98 34 3428 0000 vah_mirzaee@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Ability to speak and understand Farsi language Full consciousness Hearing and vision health 15 years 55 years Both History of gastrointestinal endoscopy History of high blood pressure under medical treatment Unwillingness to continue cooperation in the study K27 K30 K26 K92.2 Peptic ulcer, site unspecified Functional dyspepsia Duodenal ulcer Gastrointestinal hemorrhage, unspecified Rehabilitation Rehabilitation N/A The first intervention group: listening to a nature background music through headphones during endoscopy process The second intervention group: partner's hand holding during the endoscopy process Control group: without any intervention Stress score in perceived stress questionnaire. Timepoint: Stress measurement before the intervention and 2 hours after the completion of the intervention process. Method of measurement: Cohen's Perceived Stress Questionnaire. Pain score on visual pain scale. Timepoint: Pain assessment before the intervention and 2 hours after the completion of the intervention process. Method of measurement: Visual pain scale. Rafsanjan University of Medical Sciences Approved 2020-12-12 Ethics committee of Rafsanjan University of Medical Sciences University of medical sciences, Imam Ali Blvd., Rafsanjan Town Rafsanjan Kerman Iran (Islamic Republic of)