Protocol summary

Summary
The aim of this study was to compare the effect of relaxation and support group on anxiety in nursing students. The study is intervention, comparative, randomized controlled trial and is single blind. The main criteria for inclusion: according to the Spielberger questionnaire test, they had mild, moderate and severe anxiety; No history of psychiatric disorders and sedative drugs. Main exclusion criteria: absence of more than two sessions in class; absence of one of the meetings pre or post test.The study population and sample size: 150 nursing students were selected according to inclusion criteria then nursing students randomly will be divided into case and control groups. Interventions: Before the beginning, first the pre-test was obtained from samples.Then in the first week of Interventions, the progressive muscle relaxation technique for 5 consecutive 45-minutes sessions was carried out, while students were practicing at home for ten minutes. The method of support groups, in the second week for 5 sessions of 45 minutes was carried out. In the end, samples were taken and the results were compared. The control group received no intervention. The time of intervention, a week after the completion of the sampling. Primary outcomes: reduction of anxiety in students.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030221298N1
Registration date: 2015-06-27, 1394/04/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Sanaz Bostani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
sanaz.bostani@gmail.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-06, 1394/01/17
Expected recruitment end date
2015-05-07, 1394/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of relaxation and support group on anxiety in nursing students
Public title
Comparison of the effect of relaxation and support group on anxiety in nursing students
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: according to the Spielberger questionnaire test, they had mild, moderate and severe anxiety; No history of psychiatric disorders and sedative drugs. Exclusion criteria: absence of more than two sessions in class; absence of one of the meetings pre or post test.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Shiraz University of Medical Science
Street address
Ethics committee of Shiraz University of Medical Science, Shiraz University of Medical Science, Zand Street, Shiraz, Fars, Iran.
City
Shiraz
Postal code
71348-14336
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
CT_9370_7400

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

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

2

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

Secondary outcomes

empty

Intervention groups

1

Description
In the first group are involved relaxation. In this method Jacobson relaxation technique is used. This is the fifth consecutive session a week for 45 minutes to 50 nursing students was conducted. In all sessions students with researcher implement this technique. While this method should be practiced at home every day for 5-10 minutes. In each session, especially in the final session feedback will be about the feelings of students.
Category
Other

2

Description
Support groups are involved in the second group. This 5 consecutive sessions per week for 45-minute sessions for 50 nursing students was conducted. In this method people can be divided into 5 groups of 10 people. The members of each group under the supervision of the researcher as facilitator share experiences, hopes, solutions, ... and at the end of each session to share this experience with other groups and will be discussed. In the final session, all solutions are reviewed and taken feedback from students about different feelings.
Category
Other

3

Description
Control groups receive no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh(P.B.U.H) School of Nursing and Midwifery
Full name of responsible person
Camellia Torabizadeh, PH.D in Nursing
Street address
Fatemeh(P.B.U.H) School of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr. Sayyed Basir Hashemi
Street address
Vice chancellor for research, Shiraz University of Medical Science, Zand Street, Shiraz, Fars, Iran.
City
Shiraz
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, Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Camellia Torabizadeh
Position
PH.D in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
+98 36474252
Email
camellia_torabizadeh@yahoo.com; torabik@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Univarsity of Medical Science
Full name of responsible person
Sanaz Bostani
Position
Master Science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
+98 36474252
Email
sanaz.bostani@gmail.com; torabik@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Univarsity of Medical Science
Full name of responsible person
Sanaz Bostani
Position
Master Science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz
Postal code
1978-71345
Phone
+98 71364742548
Fax
+98 36474252
Email
sanaz.bostani@gmail.com
Web page address
nurs-midwif.sums.ac.ir

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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