History
# Registration date Revision Id
2 2019-05-20, 1398/02/30 93031
1 2014-05-27, 1393/03/06 15025
Changes made to previous revision
This is the first revision

Protocol summary

Summary
The aim of this study was to determine the effects of guided imagery on anxiety of patients before abdominal surgery. Some of inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness. In this randomized clinical trial, 116 patients undergoing appendectomy and herniorrhaphy in Sabzevar Beheshti Hospital in 2014 will be randomly assign to intervention and control groups. After the initial selection of samples, demographic data form and STAI anxiety questionnaire is completed by both groups. For the intervention group, 18-minute guided visualization CD will be played through headphones, which include visualization of the beautiful scenery and pleasant (the beach) and positively associated with increased wellness is empathy. The control group received routine care.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122315905N1
Registration date: 2014-05-27, 1393/03/06
Registration timing: retrospective

Last update:
Update count: 1
Registration date
2014-05-27, 1393/03/06
Registrant information
Name
Mahbobe Mohebbi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1386 1959
Email address
mohebbi_mhb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Guided Imagery on Preoperative Anxiety in Patients Undergoing Abdominal Surgery
Public title
The Effect of Guided Imagery on Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness; loss of hearing; having a stressful event (divorce, death of spouse or close relative, loss of a job, migration, severe accident) during the last 6 months. Exclusion criteria included: history of previous surgery; addiction; mental health and respiratory disease; having a degree in psychology and related fields; use guided imagery before the start of the study; having bitter memories of the sea and Not imagine the sea; the use of anti-anxiety drugs.
Age
From 15 years old to 49 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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Next to the police station to Shahroud road, Sabzevar.
City
Sabzevar
Postal code
Approval date
2013-11-13, 1392/08/22
Ethics committee reference number
medsab.Rec.92.1

Health conditions studied

1

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

Primary outcomes

1

Description
Preoperative Anxiety
Timepoint
Before surgery
Method of measurement
Spielberger Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
In addition to routine care, interventional group listened to guided imagery audio CD, one hour before surgery for 18 minutes.
Category
Other

2

Description
Control group received only routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Beheshti Hospital
Full name of responsible person
Mahbobe Mohebbi
Street address
Razi Street
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Moosareza Tadayonfar
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mahbobe Mohebbi
Position
Senior student of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
City
Sabzevar
Postal code
Phone
+98 51 1386 1959
Fax
Email
mohebbi_mhb@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr Moosareza Tadayonfar, Faculty Member of Sabzevar University of Medical Science
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar.
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
mtadayonfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahbobe Mohebbi
Position
senior student of Nursing
Other areas of specialty/work
Street address
Next to the police station to SHahroud road, Sabzevar.
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
mohebbi_mhb@yahoo.com
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
Loading...