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IRCT20190126042497N1 IRCT 2019-02-05 Yasouj University of Medical Sciences combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety ACS Comparison of combination effect of Benson’s relaxation technique and Foot bath on Quality of Sleep and Anxiety in patients with Acute Coronary Syndrom 2019-02-07 anticipated 64 Complete https://irct.ir/trial/37167 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Patients with acute coronary syndrome are selected by non probabilistic sampling, but randomly assigned to four intervention groups. In this method, all four states of the group are written on 16 cards and each will be placed in a sealed envelope. These packs are placed in a box, and the researcher does not know which groups of items are to be examined before choosing any of the envelopes. Prior to exposing the units, the researcher assisted in removing one of the envelopes from the box, in which of the 4 illnesses that entered the study would be included. N/A Condition 1: Sleep. Condition 2: Anxiety. Intervention 1: Intervention group: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed every night befor bedtime for three consecutive days by patients and supervised by the researcher. Intervention 2: Intervention group: the warm Foot baths will perform for three consecutive nights for patients with 40 ° C water for 30 minutes, 1hour before bedtime. Legs up to 10 cm above the ankle will dip in a special plastic container. SMHSQ questionnaire and Beck Anxiety Inventory (BAI) questionnaire will be completed every day during the 7 to 8 am. Intervention 3: Intervention group: Combination: The patients in the combined group are asked to first bath their feet in water for 30 minutes and then Perform relaxation for 20 minutes in accordance with the above mentioned protocols. Intervention 4: Control group: In the control group, nothing will be done in 3 consecutive nights of intervention, but The SMHSQ questionnaire will be completed for three days and each day during 7 to 8 am. Yes - There is a plan to make this available What will be shared: General data such as demographic variables and outcomes under study will be published. When: Get started 6 months after printing results To whom: All researchers working in academic and scientific institutions who want the results of the study will be allowed to receive the data Conditions: Data can be used to enhance science and use results in research Where to obtain: School of Nursing & Midwifery, Rashid Yasemi St, Vali Asr St,Tehran 00982143651000 nsahraea@gmail.com How to obtain: Once requested, the data will be delivered electronically or in person within one week. Comments:
public Hoda Arianpour
Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences
Gchsaran Iran (Islamic Republic of) 75917-41417 +98 74 2222 4811 hoda.aryanpour@yums.ac.ir Yasouj University of Medical Sciences scientific Marzieh Hosseini
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery.
Yasouj Iran (Islamic Republic of) 75917-41417 +98 74 3333 7230 m.hosseini235@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Patients with Acute Coronary Syndrome lack of anxiety or chronic psychatric disorder First time admission in CCU ward Passed at least one night from the patient's hospitalization having written knowingly informed consent Interest in program participation lack of acute or chronic illness At least reading and writing skills Age 65-32 years old Having healthy health (hearing and legs) Complete alert lack of membership in medical treatment services A score of 25-16 (moderate anxiety) was obtained based on Beck's questionnaire Sleeping and relaxing medications are the same Lack of mental and motor disorders Not having eczema or any type of ulcer in your legs Not having diabetic ulcer or diabetic neuropathy diagnosis lack of corporate programs of relaxation; Foot bath and similar techniques 32 years 65 years Both Failure to motivate the patient to continue cooperation Exacerbation of the disease for a period of intervention Death of the patient F51.2 F41.9 Nonorganic disorder of the sleep-wake schedule Anxiety disorder, unspecified Behavior Other Behavior Other Intervention group: Benson relaxation technique: The Benson's muscle relaxation is performed by the patient in six steps. 1- Stay in a comfortable position 2. Close eyes. 3. Expansion the muscles of the body from the tip to the head 4. Performing the inhale through the nose and exhaling through the mouth and whisper the word desired when exhaling. 5- Perform the above steps for 20 minutes, then open the eyes and do not move for a few minutes. 6. Lack of worry and ignoring disturbing thoughts during relaxation. During the intervention, remove the disturbing thoughts from your mind as much as possible and choose a word that has always reminded him of calm, such as (God, love, sea). Instructions for doing these steps will be provided through the MP3 player and headphones. In this audio file, the instructions are set for 20 minutes and there is no need to set the clock to determine the method duration. In this file, 30 seconds before the completion of the technique, a gentle song will be put to inform the patient about the end of the procedure. To perform muscle relaxation by pulling the curtains at the patient's bed, the patient's privacy is observed and the privacy of the person and providing a quiet and silent environment for sitting with the department's officials is coordinated so that nobody gets into the patient's unit. One day after training the procedures In addition to the usual care of the department, Benson's relaxation procedure is performed every night befor bedtime for three consecutive days by patients and supervised by the researcher. Intervention group: the warm Foot baths will perform for three consecutive nights for patients with 40 ° C water for 30 minutes, 1hour before bedtime. Legs up to 10 cm above the ankle will dip in a special plastic container. SMHSQ questionnaire and Beck Anxiety Inventory (BAI) questionnaire will be completed every day during the 7 to 8 am. Intervention group: Combination: The patients in the combined group are asked to first bath their feet in water for 30 minutes and then Perform relaxation for 20 minutes in accordance with the above mentioned protocols. Control group: In the control group, nothing will be done in 3 consecutive nights of intervention, but The SMHSQ questionnaire will be completed for three days and each day during 7 to 8 am. Quality of Sleep. Timepoint: Measurement of Sleep Quality before the onset of intervention and on the morning of the third, fourth and fifth day of admission after the start of Benson's relaxation & Foot bath. Method of measurement: St Mary’s Hospital Sleep Questionnaire (SMHSQ). Anxiety. Timepoint: Measurement of Anxiety before the onset of intervention and on the morning of the third, fourth and fifth day of admission after the start of Benson's relaxation & Foot bath. Method of measurement: Beck Anxiety Inventory (BAI). Yasouj University of Medical Sciences Approved 2018-12-22 Ethics committee of Yasouj University of Medical Sciences Dr. Shahid Motahari Blvd., Yasouj University of Medical Sciences Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)