Protocol summary

Summary
Objectives: This study aimed to examine the effects of CBT on self-esteem and quality of life of hospitalized amputee elderly patients. A quasi-experimental study with pretest-posttest design was carried out on a sample of 64 amputee elderly patients admitted to the Vascular Surgery unit of the Al-Zahra hospital, Isfahan, Iran. The subjects were selected consecutively and then were randomly assigned into either the experimental or the control groups (32 patients in each group). The intervention group was divided into small subgroups of 3 to 4 patients and each subgroup participated in six sessions of cognitive-behavioral therapy according to the Turkington and Kingdon model.The CBT sessions were held twice a week, in three successive weeks. All the sessions were held in a comfortable room in the surgical ward. The control group received routine care. After the third week, all patients in the both groups were invited to the surgical ward and answered the Rosenberg self-esteem scale and the WHOQoL-short form for the second time. inclusioncriteria: The inclusion criteria were: age of 60 years and over, ability to read and write in Farsi language, being conscious and aware of time and place, having no psychological disorder, having no mental, visual and hearing problem. exclusion criteria: The exclusion criteria were confronting with any problem i.e. disability or death that interfere with participating in the study.

General information

Acronym
Do not have
IRCT registration information
IRCT registration number: IRCT2016092730002N1
Registration date: 2016-11-09, 1395/08/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-09, 1395/08/19
Registrant information
Name
Mousa Alavi
Name of organization / entity
Department of Psychiatric Nursing, Nursing and Midwifery Care
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7588
Email address
m_alavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of cognitive behavioral therapy on self-esteem and Quality of life in the amputated older patients, hospitalized
Public title
The Effect of cognitive behavioral therapy on self-esteem and Quality of life
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The inclusion criteria were: age of 60 years and over; ability to read and write in Farsi language; being conscious and aware of time and place; having no psychological disorder; having no mental, visual and hearing problem. The exclusion criteria were confronting with any problem i.e. disability or death that interfere with participating in the study.
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
University of Medical Sciences, Hezar Jarib street,Isfahan--
City
Isfahan
Postal code
81745-319
Approval date
2015-08-17, 1394/05/26
Ethics committee reference number
IR.MUI.REC.1394.1.041

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
self-esteem
Timepoint
preintervention/immédiatement postintervention
Method of measurement
Rosenberg self-esteem scale

2

Description
Quality of Life
Timepoint
preintervention/ immédiatement post intervention
Method of measurement
Questionnaire (WHOQoL-short form)

Secondary outcomes

1

Description
do not have
Timepoint
do not have
Method of measurement
do not have

Intervention groups

1

Description
Intervention group : cognitive behavioral therapy Patients in the intervention group participated in six sessions of cognitive-behavioral therapy. The CBT sessions were held twice a week, in three successive weeks. The control group received routine care.The outline of the CBT sessions :Greeting and introducing the sessions’ facilitator and the patients to each other; briefing the patients on the numbers and the structure of the educational sessions; Introducing the cognitive-behavioral intervention; presenting the concepts and the importance of self-esteem and quality of life and provide examples of these concepts; providing some assignments (i.e. identifying instances of self-esteem and quality in him/her life). Greeting, reviewing the content of the previous session and receiving the patients’ feedback; presenting the concept of self-knowledge (familiarity with him/her thoughts and how to analysis them), providing strategies to identify him/her strengths and weaknesses; providing some assignments (i.e. identifying examples of the real strengths and weaknesses of him/herself). Greeting, reviewing the content of the previous session and receiving the patients’ feedback; introducing the factors affecting self-esteem and quality of life; teaching the patients about self-control and problem solving; providing some assignments (i.e. identifying instances affecting self-esteem and quality of life of the patients in their real life). Greeting, reviewing the content of the previous session and receiving the patients’ feedback; presenting some strategies for cognitive restructuring and how to reorganize his/her thoughts and beliefs; providing some assignments for cognitive restructuring and exercises for reorganizing his/her thoughts and beliefs. Greeting, reviewing the content of the previous session and receiving the patients’ feedback; presenting methods for logical behavior analysis, behavior change, relaxation, visual imagery; providing some assignments for behavior change, relaxation, visual imagery by the patients. Greeting, reviewing the content of the earlier sessions and receiving the patients’ feedback; presenting some strategies to reinforce positive thoughts and negative behaviors, improvement of coping skills, and providing some assignments to be done at the end of the session.
Category
Behavior

2

Description
Control group:The control group received routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-zahra vscualar surgery ward
Full name of responsible person
Razieh Molavi
Street address
Al-zahra Hospital, Hakim NezamiThree- way, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical Sciences Vice chancellor for research, Isfahan University of
Full name of responsible person
Seid Mohamad Hashemi
Street address
Hezar Jarib street,Chancellor for research of, Isfahan University of Medical Sciences
City
Isfahan
Grant name
-
Grant code / Reference number
- -
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Sciences Vice chancellor for research, Isfahan University of
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
Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Razieh Molavi
Position
MSc in elderly Nursing
Other areas of specialty/work
Street address
Home Karimi, Abdullahi deadlock, Alley martyr Eshaghi, South malek street,Isfahan
City
Isfahan
Postal code
8154739111
Phone
+98 31 3264 7292
Fax
+98 31 4583 7934
Email
raziehmolavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Razieh Molavi
Position
MSc in elderly Nursing
Other areas of specialty/work
Street address
Home Karimi, Abdullahi Deadlock, AlleyMartyr Eshaghi, South malek street,Isfahan
City
Isfahan
Postal code
8154739111
Phone
+98 31 3264 7292
Fax
+98 31 4583 7934
Email
raziehmolavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Razieh Molavi
Position
MSc in elderly Nursing
Other areas of specialty/work
Street address
Home Karimi, Abdullahi Deadlock, Alley Martyr Eshaghi, South malek street,Isfahan
City
Isfahan
Postal code
8154739111
Phone
+98 31 3264 7292
Fax
+98 31 4583 7934
Email
raziehmolavi@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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