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IRCT20210307050609N2 IRCT 2022-04-11 Rasht University of Medical Sciences The effect of music on pain and agitation after septorhinoplasty The effect of playing music during surgery on postoperative pain and agitation in patients undergoing septorhinoplasty: a clinical trial 2022-03-06 anticipated 100 Complete https://irct.ir/trial/62144 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization will be performed in 25 blocks of four, via sealed envelope software in www.sealedenvelope.com. A unique randomization code will be devoted to each randomization number group, the codes are recorded in questionnaires. the interventioner will play file 1 or 2 of playlist based on the matched code list in operating room, while unaware of playlist, Blinding description: At the time of history taking , a coded checklist will be put in patients records. Decoding is inaccessible for everyone except for intervention-er. the intervention-er who is in operation room is not in touch with patient and wont see the code before entrance of patient to operation theater. All the checklists are gathered by residents who are unaware of codes and grouping. List of codes are kept in an envelope in a locked case in operation room, lock is kept by secretory. The surgeon, surgical technician, and patients are unaware of groups before beginning of intervention. Surgical technician, anesthesiologist and anesthesiology technician are unaware of music played in earphones. During induction the resident will play playlist 1 (music) or 2(silence), based on the code. surgical aid circular will record operation time, pulse rate and mean arterial pressure. Anesthesiologist colleague will record agitation-sedation score. Patient satisfaction will be recorded in ward by a resident. N/A pain and agitation after surgery. Intervention 1: Intervention group: music played via earphone during surgery. In study group instrumental music (piano played by master Javad Maroofi, with a mean rhythm of 80 bytes per minute and with a intensity of 50-65 dB) will be played from induction phase till the end of the operation. Intervention 2: Control group: silence played via earphones during surgery. Yes - There is a plan to make this available What will be shared: all data can be shared after omitting personal information When: after submitting the article To whom: researchers in academic fields Conditions: just as a reference for their own studies Where to obtain: email to cor-responder How to obtain: sending an email, receiving the data after evaluating the request Comments:
public Sevil Nasirmohtaram
No.17 , 108 Ave.,Golsar Blvd
Rasht Iran (Islamic Republic of) 4165755199 +98 13 3211 9653 sevil198@yahoo.com Rasht University of Medical Sciences scientific Sevil Nasirohtaram
No. 17, 108 Ave., Golsar Blvd.
Rasht Iran (Islamic Republic of) 4165755199 +98 13 3211 9653 sevil198@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) candidates of septorhinoplasty 18 years 65 years Both known cases of mood disorder known cases of hearing or cognitive problems history of drug or alcohol abuse history of antidepressant or tranquilizers usage complex septorhinoplasty which requires specific techniques like harvesting conchal or costal cartilage and prolonged operation time F-41 other anxiety disorders Treatment - Other Placebo Intervention group: music played via earphone during surgery. In study group instrumental music (piano played by master Javad Maroofi, with a mean rhythm of 80 bytes per minute and with a intensity of 50-65 dB) will be played from induction phase till the end of the operation. Control group: silence played via earphones during surgery Agitation after surgery. Timepoint: evaluation of agitation during extubation and in recovery ward. Method of measurement: with sedation-agitation score. Pain after surgery. Timepoint: in recovery ward. Method of measurement: with visual analogue scale. Patient satisfaction of operation process. Timepoint: once in ward. Method of measurement: checklist based on patient's declaire. Rasht University of Medical Sciences Approved 2022-02-04 Gilan University of medical sciences Amir-almomenin hospital, 17 shahrivar Ave. Rasht Guilan Iran (Islamic Republic of)