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IRCT20231024059844N1 IRCT 2023-11-23 Zabol University of Medical Sciences Comparison of the effect two methods of rhythmic breathing and music therapy on pain intensity, anxiety and hemodynamic indicators of patients after orthopedic surgery Comparison of the effect two methods of rhythmic breathing and music therapy on pain intensity, anxiety and hemodynamic indicators of patients after orthopedic surgery 2023-11-06 anticipated 90 Complete https://irct.ir/trial/73463 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, research samples will be selected from among the patients who refer to Shahid Chamran Hospital in Shiraz for orthopedic surgery and meet the criteria for entering the research, and will be randomly assigned (so that the first sample of the research In the first intervention group (rhythmic breathing), the next sample in the second intervention group (music therapy) and the next sample in the control group) patients will be placed in three groups until the sample size is completed, Blinding description: This study will be conducted as a one-sided blind controlled clinical trial (one-sided blind: the meaning is that the subjects do not know which of the groups they are in). N/A Orthopedic surgery. Intervention 1: Intervention group:For the first group (rhythmic breathing), before the operation (when the patient's condition is necessary), the researcher will teach how to perform rhythmic breathing in such a way that the patients are able to do this. After the patient regains consciousness and it is confirmed by the anesthesiologist, during the first 24 hours, i.e. at the end of the first 12 hours and at the end of the second 12 hours after the patient regains consciousness, rhythmic breathing by the patient for 20 minutes while In each stage, they count from 1 to 3 and while breathing, they only focus on the inflow and outflow of air, once every five minutes, one minute each time, and immediately after each stage, the intensity of pain is controlled using a visual pain control scale. will be. In addition, their pulse rate, blood pressure and anxiety (Spielberger questionnaire) will be controlled at the same time as pain intensity and will be compared with other groups. Intervention 2: Intervention group: For the second group (music therapy) there are also wordless and arbitrary musics (from among the four wordless musics of Baran Eshgh by Nasser Chashm Azar and three works by Dr. Arendstein called Peace in Dreams and two motivational pieces) for each of patients will be used and before the operation these musics will be played for each patient and their desired music will be selected. In this group, after the patient regains consciousness and is confirmed by the anesthesiologist, during the first 24 hours, i.e. at the end of the first 12 hours and at the end of the second 12 hours after the patient regains consciousness, the music they want is played through The music player (headphones) will be played for 20 minutes for each patient and immediately after each stage, pain intensity (visual pain scale), pulse rate, blood pressure and anxiety (Spielberger questionnaire) will be controlled in each of the research samples. It will be compared with other groups. Intervention 3: Control group: It will include patients for whom no intervention will be performed and they will only be under the usual care of the hospital, and at the end of the first 12 hours and the second 12 hours after surgery, their pain intensity, anxiety level and hemodynamic indicators will be controlled. and will be compared with other groups. It should be noted that in all three groups, in case of need for housing or any other care, the required medical care will be performed according to the routine and none of these cares will be omitted. No - There is not a plan to make this available Justification or reason for not sharing IPD is There are no plans to release it
public Mitra Zarei
Shiraz - Golestan town - Baharestan street - 13 alley - left side - first building - third floor - unit 6
Shiraz Iran (Islamic Republic of) 7189838786 +98 71 3620 3184 mytrazary754@gmail.com Zabol University of Medical Sciences scientific Dr. Hossein Shahdadi
Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St., next to the registry office
Zabol Iran (Islamic Republic of) 9861734184 +98 54 3222 3947 zb5950@gmail.com Zabol University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the research Having at least reading and writing literacy Not suffering from mental disorders based on medical records No history of taking psychiatric drugs and anti-anxiety drugs in the last 6 months Age 30 to 70 years Performing orthopedic surgery on the lower limb or placing an internal fixator No previous history of fracture and orthopedic surgery A fracture in a lower limb or the need for a fixator in a limb No trauma to the head, chest and abdomen No hearing disorders Hospitalization after surgery No respiratory disease (asthma, bronchitis, etc.) No diabetes No drug addiction Analgesic injection more than 4 hours before measuring the desired variables 30 years 70 years Both Withdrawal from participating in the research Need for re-surgery during the study Getting other diseases while doing research The use of local drugs or other measures (hypnosis, distraction, etc.) that can affect pain, anxiety, or hemodynamic indicators during the study. Analgesic injection less than 4 hours before measuring the desired variables Z47.82 Encounter for orthopedic aftercare following scoliosis surgery Treatment - Other Treatment - Other Treatment - Other Intervention group:For the first group (rhythmic breathing), before the operation (when the patient's condition is necessary), the researcher will teach how to perform rhythmic breathing in such a way that the patients are able to do this. After the patient regains consciousness and it is confirmed by the anesthesiologist, during the first 24 hours, i.e. at the end of the first 12 hours and at the end of the second 12 hours after the patient regains consciousness, rhythmic breathing by the patient for 20 minutes while In each stage, they count from 1 to 3 and while breathing, they only focus on the inflow and outflow of air, once every five minutes, one minute each time, and immediately after each stage, the intensity of pain is controlled using a visual pain control scale. will be. In addition, their pulse rate, blood pressure and anxiety (Spielberger questionnaire) will be controlled at the same time as pain intensity and will be compared with other groups. Intervention group: For the second group (music therapy) there are also wordless and arbitrary musics (from among the four wordless musics of Baran Eshgh by Nasser Chashm Azar and three works by Dr. Arendstein called Peace in Dreams and two motivational pieces) for each of patients will be used and before the operation these musics will be played for each patient and their desired music will be selected. In this group, after the patient regains consciousness and is confirmed by the anesthesiologist, during the first 24 hours, i.e. at the end of the first 12 hours and at the end of the second 12 hours after the patient regains consciousness, the music they want is played through The music player (headphones) will be played for 20 minutes for each patient and immediately after each stage, pain intensity (visual pain scale), pulse rate, blood pressure and anxiety (Spielberger questionnaire) will be controlled in each of the research samples. It will be compared with other groups Control group: It will include patients for whom no intervention will be performed and they will only be under the usual care of the hospital, and at the end of the first 12 hours and the second 12 hours after surgery, their pain intensity, anxiety level and hemodynamic indicators will be controlled. and will be compared with other groups. It should be noted that in all three groups, in case of need for housing or any other care, the required medical care will be performed according to the routine and none of these cares will be omitted. Intensity of pain. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Pain Visual Scale Questionnaire. The level of anxiety. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Spielberger questionnaire. Pulse count. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Pulse count in one minute. Blood pressure. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Measurement by pressure gauge. Intensity of pain. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Visual analog scale questionnaire. The level of anxiety. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Spielberger questionnaire. Pulse count. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Pulse count in one minute. Blood pressure. Timepoint: The first 12 hours and the second 12 hours after surgery. Method of measurement: Measurement by pressure gauge. Zabol University of Medical Sciences Approved 2023-10-11 Ethics Committee of Zabul University of Medical Sciences Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St., next to the registry office zabol Sistan-va-Balouchestan Iran (Islamic Republic of)