Protocol summary

Summary
The aim of this study was the comparison the effect of relaxation and praying on preoperative anxiety in patients who admitted in Ayatollah Kashani Hospital in Shahrekord. This study was a quasi-experimental, not-blinded study with simple random allocation. 116 patients who were candidate for abdominal surgery were allocated randomly into praying (n=54), relaxation(n=30), and control (n=32) groups. Inclusion criteria were age 18 to 65 years old, not treated with anxiolytic or sedative drugs during hospitalization, and candidate for abdominal surgery. Exclusion criteria were psychological disorders, hearing loss, and unwillingness to continue participation in the study. In relaxation group, Benson relaxation technique was educated for the patients by video tap, then in the day before surgery, the patients did relaxation two times( each time 15 minutes) every two hours. In praying group, in the day before surgery, the patients did praying two times( each time 15 minutes) every two hours. In the control group, the patients received preoperative routine care. Vital sign and anxiety level in each group were evaluated in two steps: before the intervention( the day before surgery) and immediately before the surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121813768N5
Registration date: 2014-01-03, 1392/10/13
Registration timing: na

Last update:
Update count: 0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Ali Hassanpour Dehkordi
Name of organization / entity
Shahrekord Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 1699
Email address
ali@skums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2008-05-21, 1387/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of relaxation and praying on preoperative anxiety of patients referred to Ayatollah Kashani Department of Surgery, Shahrekord
Public title
Comparison the effect of relaxation and praying on preoperative Anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years old, not treated with anxiolytic or sedative drugs during hospitalization, and candidate for abdominal surgery. Exclusion criteria: psychological disorders, hearing loss, and unwillingness to continue participation in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord Medical University of Sciences
Street address
Rahmatiee, Shahrekord Medical University of Sciences
City
Shahrekord
Postal code
Approval date
2008-06-08, 1387/03/19
Ethics committee reference number
87-4-1

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention and imediately before surgery
Method of measurement
Speilberger Anxiety Inventory

Secondary outcomes

1

Description
Vital sign
Timepoint
Before the intervention and imediately before surgery
Method of measurement
Inspection

Intervention groups

1

Description
Praying group: In praying group, in the day before surgery, the patients did praying two times( each time 15 minutes) every two hours.
Category
Prevention

2

Description
Control group: In the control group, the patients received preoperative routine care.
Category
Prevention

3

Description
Relaxation group: In relaxation group, Benson relaxation technique was educated for patients by video tap, then in the day before surgery, the patients did relaxation two times( each time 15 minutes) every two hours.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Ayatollah Kashani Hospital, Parastar Street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Aytollah Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord Medical University of Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Assistant Professor
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord Medical University of Sciences
City
Shahrekord
Postal code
8814814636
Phone
+98 38 1333 5652
Fax
Email
ali@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord Medical University of Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Assistant Professor
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord Medical University of Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
ali@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord Medical University of Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Assistant Professor
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord Medical University of Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
ali@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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