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IRCT20210828052307N1 IRCT 2021-09-19 Hamedan University of Medical Sciences Comparison of the effect of rhythmic breathing with subjective imaging on pain Comparison of the effect of rhythmic breathing with subjective imaging on pain intensity during spinal needle insertion in patients undergoing spinal anesthesia 2021-10-23 anticipated 120 Complete https://irct.ir/trial/58460 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be randomly assigned to one of three groups in order of entry. In order to be randomized, sixth blocks (ABABCC-ACABBC-BAACCB-ACCBAB-CBCABA-AABBCC - CCBAAB-CABABC-BCABCA, etc.) will be prepared according to the number of participants and placed in envelopes. Then, when the patients enter the study, one of the envelopes is removed from the bag by one of the nurses who has no role in the study and is sampled without permutation. N/A Pain when inserting a spinal needle. Intervention 1: In first intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the rhythmic breathing group, patients are asked to perform rhythmic breathing before inserting a spinal needle as follows: close their eyes and do a deep, long breath through the nose with three numbers, then breathe in the lungs. Hold and count to 3, and then exhale slowly through the mouth with 3 numbers. Intervention 2: In second intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the mental imaging group, after the patients are placed on the operating table just before and during the insertion of the spinal needle, a sea sound is played to the patient by a headphone and he is asked to visualize the images in his mind at the same time. Intervention 3: Control group: The patient is placed on a surgical bed, spinal anesthesia is performed by an anesthesiologist, and one minute after the procedure and the patient's hemodynamic status is confirmed, the patient is ask to indicate the severity of pain when the needle was inserted. . 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 Because the study has not started yet and we are not aware of the results of this study, we have not yet decided on how to publish these results
public Dr. Seyed Reza Borzou
Hamedan - Shahid Fahmideh Street - in front of People's Park
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۶۸۷ +98 81 3252 0182 borzou@umsha.ac.ir Hamedan University of Medical Sciences scientific Dr. Seyed Reza borzou
Hamedan - Shahid Fahmideh Street - in front of People's Park
Hamedan Iran (Islamic Republic of) 38698 65178 +98 81 3838 0545 borzou@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Ability to communicate verbally No specific disease No anatomical problems in the lumbar area and skin No neurological disorders, plagia and paresis in the area of the lower thoracic vertebrae 18 years 75 years Both Need to try to insert the needle more than once Lack of patient cooperation during spinal needle insertion Use of other methods to reduce pain Use of sedatives and hypnotics Other Prevention Other In first intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the rhythmic breathing group, patients are asked to perform rhythmic breathing before inserting a spinal needle as follows: close their eyes and do a deep, long breath through the nose with three numbers, then breathe in the lungs. Hold and count to 3, and then exhale slowly through the mouth with 3 numbers. In second intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the mental imaging group, after the patients are placed on the operating table just before and during the insertion of the spinal needle, a sea sound is played to the patient by a headphone and he is asked to visualize the images in his mind at the same time. Control group: The patient is placed on a surgical bed, spinal anesthesia is performed by an anesthesiologist, and one minute after the procedure and the patient's hemodynamic status is confirmed, the patient is ask to indicate the severity of pain when the needle was inserted. . Pain when inserting a spinal needle. Timepoint: Pain will be measured immediately after spinal anesthesia. Method of measurement: using a Visual Analogue Scale (VAS). Hamedan University of Medical Sciences Approved 2021-08-01 Ethics Committee of Hamadan University of Medical Sciences Hamadan, Shariati Crossroads, Ayatollah Kashani Blvd., Hamadan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)