Protocol summary

Summary
The aim of this research was to study the effect of therapeutic touch on state and trait anxiety in patients with irritable bowel syndrome. Inclusion criteria: having at least five year literacy؛ diagnosed with irritable bowel syndrome؛ lack of physical or psychological disorder؛ obtain a minimum score of 32 on the Spielberger anxiety inventory. Exclusion criteriA: major change in diet or lifestyle of patient؛ absence in therapeutic touch session. Intervention group, 4 times (once a week for 26 minutes) were receiving therapeutic touch. The research sample was 24 patients with irritable bowel syndrom that randomaly were assigned in intervention and control groups. The primary outcome variables: state anexiety and trait anexiety.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042913168N1
Registration date: 2013-06-03, 1392/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Mehdi Taheri
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 8832 9220
Email address
taheri.20000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kharazmi University
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-04-18, 1389/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of four sessions therapeutic touch on decreasing the outpatients anxiety with irritable bowel syndrome
Public title
The effect of therapeutic touch on patients anxiety with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having at least five year literacy؛ Diagnosed with irritable bowel syndrome؛ Lack of physical or psychological disorder؛ Obtain a minimum score of 32 on the Spielberger anxiety inventory Exclusion criteria: Major change in diet or lifestyle of patient؛ Absence in therapeutic touch session
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
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
Kharazmi University
Street address
No.43, Mofateh Ave.
City
Tehran
Postal code
1571914911
Approval date
2010-02-09, 1388/11/20
Ethics committee reference number
1414731-00

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K 58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
State anxiety
Timepoint
Before and after of the intervention
Method of measurement
Spielberger state anxiety inventory

2

Description
Trait anxiety
Timepoint
Before and after of the intervention
Method of measurement
Spielberger trait anxiety inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group, 4 times (once a week for 26 minutes) were receiving therapeutic touch.
Category
Treatment - Other

2

Description
No intervention
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Dr. Molavi
Street address
No. 68, Green Doctors Building, Taleghani Crossroad
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Mehdi Taheri
Street address
No.43, Mofateh Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
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
Kharazmi University
Full name of responsible person
Mehdi Taheri
Position
Master of Psychology
Other areas of specialty/work
Street address
No.43, Mofateh Ave.
City
Tehran
Postal code
Phone
+98 21 8832 9220
Fax
Email
Taheri.20000@Yahoo.Com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Mehdi Taheri
Position
Master of Psychology
Other areas of specialty/work
Street address
No.43, Mofateh Ave.
City
Tehran
Postal code
Phone
+98 21 8832 9220
Fax
Email
Taheri.20000@Yahoo.Com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Mehdi Taheri
Position
Master of Psychology
Other areas of specialty/work
Street address
No.43, Mofateh Ave.
City
Tehran
Postal code
Phone
Fax
Email
Taheri.20000@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
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