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IRCT20190426043375N1 IRCT 2020-01-29 Arak University of Medical Sciences Effect of diaphragmatic breathing on anxiety, quality of sleep and pain of patients candidate for lumbar discectomy Effect of diaphragmatic breathing on anxiety, quality of sleep and pain of patients candidate for lumbar discectomy 2020-02-09 anticipated 70 Complete https://irct.ir/trial/45274 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be selected based on inclusion criteria. Purposeful sampling and then patients are randomly divided into intervention and control groups. In order to comply with the Concealment, the problem of imbalance between the groups is solved by Balanced block randomization with the size of 2, 4 and 6 blocks. These blocks will then be arranged randomly using a random number table, and individuals will be assigned to two groups according to A and B. This process is repeated until the sample volume is complete, Blinding description: Outcome evaluators and expert statistics are not aware of the type of intervention and grouping. N/A Condition 1: anxiety. Condition 2: sleep. Condition 3: pain. Intervention 1: Intervention group:The researcher visits patients the night before surgery and completes a demographic questionnaire. Patients' anxiety will be measured using the Spielberger questionnaire. The researcher will practically teach the diaphragmatic breathing and ensure that the breathing is learned by the patient doing it correctly. Research units are required to perform this breathing exercise an hour before bedtime. Diaphragmatic breathing One hour before bedtime, a researcher in the test group will be reminded of the diaphragmatic respiratory test unit's presence in the hospital. At 7am after patients wake up, sleep quality of last night will be measured by St. Mary's Hospital Sleep Questionnaire. One hour before transferring the research units to the operating room, they will be asked to breathe in the diaphragm. Then, before entering the operating room, patients' anxiety levels will be measured by the Spielberger questionnaire. Postoperative pain will be measured immediately after the patient's full consciousness after surgery using visual analogue scale. Intervention 2: Control group:The researcher will meet patients at the beginning of the night shift and complete a demographic questionnaire and patients' anxiety will be measured using the Spielberger questionnaire. At 7 o'clock in the morning after the patients wake up, the quality of their sleep last night will be measured by the St. Marie Questionnaire. Then, immediately before entering the operating room, the anxiety level will be measured by the Spielberger questionnaire. Postoperative pain will be measured immediately after the patient's complete consciousness after surgery using a visual scale. 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 Given that this study is a thesis and has not yet been completed, no decision has yet been made to publish it.
public Yasaman Pourandish
School of Nursing; University Complex Payambar Azam; Sq Basij; Sardasht.
Arak Iran (Islamic Republic of) 3831667493 +98 86 3417 3507 y.pourandish@gmail.com Arak University of Medical Sciences scientific Davood Hekmatpou
School of Nursing ; University Complex Payambar Azam; Sq Basij; Sardasht.
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 hekmatpou@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Over 18 years of age fluency in Persian No chronic pain No history of surgery No drug addiction No use of any sedative and analgesics in the past 24 hours mental health Not knowing about diaphragmatic breathing 18 years no limit Both Withdrawal from continuing study death possible complications of surgery and anesthesia. F06.4 F51 G89.1 Anxiety disorder due to known physiological condition Sleep disorders not due to a substance or known physiological condition Acute pain, not elsewhere classified Treatment - Other Treatment - Other Intervention group:The researcher visits patients the night before surgery and completes a demographic questionnaire. Patients' anxiety will be measured using the Spielberger questionnaire. The researcher will practically teach the diaphragmatic breathing and ensure that the breathing is learned by the patient doing it correctly. Research units are required to perform this breathing exercise an hour before bedtime. Diaphragmatic breathing One hour before bedtime, a researcher in the test group will be reminded of the diaphragmatic respiratory test unit's presence in the hospital. At 7am after patients wake up, sleep quality of last night will be measured by St. Mary's Hospital Sleep Questionnaire. One hour before transferring the research units to the operating room, they will be asked to breathe in the diaphragm. Then, before entering the operating room, patients' anxiety levels will be measured by the Spielberger questionnaire. Postoperative pain will be measured immediately after the patient's full consciousness after surgery using visual analogue scale. Control group:The researcher will meet patients at the beginning of the night shift and complete a demographic questionnaire and patients' anxiety will be measured using the Spielberger questionnaire. At 7 o'clock in the morning after the patients wake up, the quality of their sleep last night will be measured by the St. Marie Questionnaire. Then, immediately before entering the operating room, the anxiety level will be measured by the Spielberger questionnaire. Postoperative pain will be measured immediately after the patient's complete consciousness after surgery using a visual scale. Level of anxiety. Timepoint: Measurement of the anxiety level at the night before surgery, one hour before the surgery. Method of measurement: State-Trait Anxiety Inventory (STAI). Sleep quality. Timepoint: The morning of surgery. Method of measurement: St. Mary's Hospital Sleep Questionnaire. Postoperative pain. Timepoint: Immediately after the patient's consciousness after surgery. Method of measurement: Visual Analogue Scale. Arak University of Medical Sciences Approved 2019-12-01 Ethics committee of Arak University of Medical Sciences Floor 3; Bldg Emam Mosaa Kazem; University of Medical Sciences Complex; Sq Basij; Sardasht Arak Markazi Iran (Islamic Republic of)