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Effect of diaphragmatic breathing on anxiety, quality of sleep and pain of patients candidate for lumbar discectomy

Protocol summary

Study aim
The effect of diaphragmatic breathing on anxiety, sleep quality and pain in selected patients with lumbar disc surgery
Design
An interventional clinical trial consisted of a group of 35 intervention and a control group of 35, with parallel groups, two blinded by the outcome assessor and the statistical expert, Block randomization
Settings and conduct
This study was a double-blind clinical trial that intervention evaluator and statistical analyzer don't know about intervention and grouping to investigate. This study will be conducted in neurosurgery ward of Vali-asr Hospital. Patients under study will be randomly divided into intervention and control groups, each containing 35 patients. intervention group received diaphragmatic breathing training and will be done one hour before sleep and operation.In the control and intervention groups, the preoperative night anxiety and one hour before the operation, the preoperative sleep quality in the morning of surgery and postoperative pain immediately after the patient is awake will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 years and up, fluency in Persian, no chronic pain, no history of surgery, no addiction, no analgesics in the past 24 hours, mental health, no prior knowledge of diaphragmatic breathing Exclusion criteria: Withdrawal during study, death and possible complications of surgery and anesthesia
Intervention groups
The patients will be randomly divided into intervention and control groups, each containing 35 patients. The intervention group received diaphragmatic breathing training the night before surgery and will be done one hour before bedtime and one hour before enter the operating room . The control group will receive routine care.
Main outcome variables
anxiety, sleep quality, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190426043375N1
Registration date: 2020-01-29, 1398/11/09
Registration timing: prospective

Last update: 2020-01-29, 1398/11/09
Update count: 0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
yasaman pourandish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 8967
Email address
y.pourandish@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diaphragmatic breathing on anxiety, quality of sleep and pain of patients candidate for lumbar discectomy
Public title
Effect of diaphragmatic breathing on anxiety, quality of sleep and pain of patients candidate for lumbar discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Withdrawal from continuing study death possible complications of surgery and anesthesia.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
Outcome evaluators and expert statistics are not aware of the type of intervention and grouping
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Floor 3; Bldg Emam Mosaa Kazem; University of Medical Sciences Complex; Sq Basij; Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.ARAKMU.REC.1398.249

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

2

Description of health condition studied
sleep
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition

3

Description of health condition studied
pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
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)

2

Description
sleep quality
Timepoint
The morning of surgery
Method of measurement
St. Mary's Hospital Sleep Questionnaire

3

Description
Postoperative pain
Timepoint
Immediately after the patient's consciousness after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Vali-asr
Full name of responsible person
Yasaman Pourandish
Street address
Vali-asr Str, Vali-asr Hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Floor 3; Bldg Emam Mosaa Kazem; University of Medical Sciences Complex; Sq Basij; Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
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
Arak University of Medical Sciences
Full name of responsible person
Yasaman Pourandish
Position
MSc Student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing; University Complex Payambar Azam; Sq Basij; Sardasht.
City
Arak
Province
Markazi
Postal code
3831667493
Phone
+98 86 3417 3507
Email
y.pourandish@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing ; University Complex Payambar Azam; Sq Basij; Sardasht.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
hekmatpou@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yasaman Pourandish
Position
MSc Student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing; University Complex Payambar Azam; Sq Basij; Sardasht.
City
Arak
Province
Markazi
Postal code
3831667493
Phone
+98 86 3417 3507
Email
y.pourandish@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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