Comparison of the effect two methods of rhythmic breathing and music therapy on pain intensity, anxiety and hemodynamic indicators of patients after orthopedic surgery
Determination and comparison of pain intensity, anxiety level and hemodynamic indicators (pulse rate and blood pressure) between three groups (rhythmic breathing, music therapy, control) in the first 24 hours (end of the first 12 hours and the second 12 hours) after orthopedic surgery.
Design
This research is a single-blind controlled clinical trial study that will be conducted on patients who undergo lower limb orthopedic surgery or internal fixator in the male and female orthopedic departments of Shahid Chamran Hospital in Shiraz in 1402.
Settings and conduct
The environment of this research is the male and female orthopedic departments of Shahid Chamran Hospital in Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion :Consent to participate in the research - have minimum reading and writing literacy - not suffering from mental disorders based on medical records...
Exclusion: - Refusal to participate in the research - Need for re-surgery during the study
Getting other diseases while doing research...
Intervention groups
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. Berger) they will also be controlled at the same time with pain intensity and will be compared with other groups.
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.
Main outcome variables
intensity of pain ; The level of anxiety ; Pulse count ; blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231024059844N1
Registration date:2023-11-23, 1402/09/02
Registration timing:registered_while_recruiting
Last update:2023-11-23, 1402/09/02
Update count:0
Registration date
2023-11-23, 1402/09/02
Registrant information
Name
Mitra Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 3184
Email address
mytrazary754@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect two methods of rhythmic breathing and music therapy on pain intensity, anxiety and hemodynamic indicators of patients after orthopedic surgery
Public title
Comparison of the effect two methods of rhythmic breathing and music therapy on pain intensity, anxiety and hemodynamic indicators of patients after orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabul University of Medical Sciences
Street address
Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St., next to the registry office
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Approval date
2023-10-11, 1402/07/19
Ethics committee reference number
IR.ZBMU.REC.1402.082
Health conditions studied
1
Description of health condition studied
Orthopedic surgery
ICD-10 code
Z47.82
ICD-10 code description
Encounter for orthopedic aftercare following scoliosis surgery
Primary outcomes
1
Description
intensity of pain
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Pain Visual Scale Questionnaire
2
Description
The level of anxiety
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Spielberger questionnaire
3
Description
Pulse count
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Pulse count in one minute
4
Description
blood pressure
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Measurement by pressure gauge
Secondary outcomes
1
Description
intensity of pain
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Visual analog scale questionnaire
2
Description
The level of anxiety
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Spielberger questionnaire
3
Description
Pulse count
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Pulse count in one minute
4
Description
blood pressure
Timepoint
The first 12 hours and the second 12 hours after surgery
Method of measurement
Measurement by pressure gauge
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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
Category
Treatment - Other
3
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital, Shiraz
Full name of responsible person
Dr. Seyed Ali Hashemi
Street address
Shiraz Shahid Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
+98 71 3623 4507
Email
chamhosp@sums.ac.ir
Web page address
https://chamran.sums.ac.ir/riasat
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Khadijah Rezaei Kikhaei
Street address
Zabol, Jihad Square, Shahid Bagheri St., Zabol University of Medical Sciences Headquarters
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
info@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mitra Zarei
Position
Master's student in internal surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz - Golestan town - Baharestan street - 13 alley - left side - first building - third floor - unit 6
City
Shiraz
Province
Fars
Postal code
7189838786
Phone
+98 71 3620 3184
Email
mytrazary754@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Hossein Shahdadi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sistan and Baluchestan province, Zabul city - 11 Ferdowsi St., next to the registry office
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
zb5950@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mitra Zarei
Position
Master's student in internal surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz - Golestan town - Baharestan street - 13 alley - left side - first building - third floor - unit 6
City
Shiraz
Province
Fars
Postal code
7189838786
Phone
+98 71 3620 3184
Email
mytrazary754@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD