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Mental health and hopefulness following laughter therapy and cognitive behavior therapy among dialysis patients

Protocol summary

Study aim
This study was aimed to examine the effects of laughter therapy (LT) and cognitive behavior therapy (CBT) on mental health and hopefulness of dialysis patients.
Design
Clinical trial with two intervention groups (n=48, each of them) and control group (n=49), computer base randomization, workshop in the hospital setting
Settings and conduct
The subjects were selected among patients undergoing dialysis in teaching hospitals affiliated to the Isfahan University of Medical Sciences: Noor and Hazrat Ali Ashgar, Al-Zahra, Amin, and Farabi.
Participants/Inclusion and exclusion criteria
The existence of patient’s permanent medical records in selected hospitals, willingness to be included in the study, the ability to read and write in Persian, absence of any signs of mental retardation, no concomitant use of medications for mental disorders, no use of other non-medication treatment, absence of any report on severe stress during the previous 6-month period, no history of participation in similar interventions and being treated with dialysis at last 6 months, were considered as inclusion criteria. Exclusion criteria consisted of unwillingness to complete intervention process, absence for more than 2 sessions, facing with major physical or mental conditions during intervention period which can affect the study results, and emigration from the region where the study will take place.
Intervention groups
Patients were assigned to 3 groups: LT (n=48), CBT (n=48) and the control group (n=49) through the computer-generated randomization procedure.
Main outcome variables
Mental health and hopefulness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101013004922N2
Registration date: 2018-02-09, 1396/11/20
Registration timing: retrospective

Last update: 2018-02-09, 1396/11/20
Update count: 0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Mohammad Sahebzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2281 1045
Email address
m_szamani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-27, 1396/01/07
Expected recruitment end date
2017-04-16, 1396/01/27
Actual recruitment start date
2017-03-27, 1396/01/07
Actual recruitment end date
2017-04-16, 1396/01/27
Trial completion date
empty
Scientific title
Mental health and hopefulness following laughter therapy and cognitive behavior therapy among dialysis patients
Public title
Laughter therapy and cognitive behavior therapy among dialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The existence of patient’s permanent medical records in selected hospitals Willingness to be included in the study The ability to read and write in Persian Absence of any signs of mental retardation No concomitant use of medications for mental disorders Absence of any report on severe stress during the previous 6-month period No history of participation in similar interventions Being treated with dialysis at last 6 months
Exclusion criteria:
Unwillingness to complete intervention process Absence for more than 2 sessions Facing with major physical or mental conditions during intervention period which can affect the study results Emigration from the region where the study was being carried out
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 145
Actual sample size reached: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Then patients were assiged to 3 groups: LT (n=48), CBT (n=48) and the control group (n=49) through the computer-generated randomization procedure.
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
Ethics Committee of Islamic Azad University Tehran Medical Sciences Branch
Street address
Tehran Province, Tehran, Danesh Rd
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.IAU.REC.1395.374

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
Mental health
Timepoint
Before and 2 days after intervention
Method of measurement
Symptom Checklist (SCL-90-R) was used before intervention and 2 days after it.

2

Description
Hopefulness
Timepoint
Before and 2 days after intervention
Method of measurement
Snyder Hope Scale (SHS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: laughter therapy: In this study, 8 one-hour Laughter Therapy (LT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) is a laughter therapist and has a certificate from the Iran Laughter Club. During the first session, exercises such as deep respiration, physical movements (clapping), induction of a feeling of gratitude toward God and laughing in a shy manner (by placing the hands over the eyes) were practiced. During the subsequent sessions, drills such as laughing with a loud sound (gaff), long laughers and other kinds of laughing were presented in association with physical exercises, deep respiration and focus on positive aspects of life.
Category
Behavior

2

Description
Intervention group B: Cognitive behavior therapy: In this study, 8 one-hour Cognitive Behaviour Therapy (CBT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) has an official certificate on cognitive‒behavioral interventions under the supervision of Dr. Mahdi Nasre Esfahani, who is a psychiatrist. The contents of the sessions were confirmed by psychologists, and they were implemented through counseling with them. The contents of each session consisted of reviewing the drills of the previous session, instructing new subjects, practicing and assigning the next session’s exercises. During the first session, some explanations were provided about the A-B-C system, behaviors and physiology. During the subsequent sessions, the cognitive therapy of mental health, positive thinking approach, classification of beliefs, data organizing, altering beliefs, rational analysis, desensitization, etc., were presented and exercised.
Category
Behavior

3

Description
Control group: Routine therapy with dialysis
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Teaching hospitals: Noor and Hazrat Ali Asgar, Al-Zahra, Amin, and Farabi
Full name of responsible person
Sima Vadaei
Street address
Ostandari st, Noor and Hazrat Ali Asgar hospital, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81387959367
Phone
+98 31 3222 2127
Email
sima_vadaei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Islamic Azad University- Tehran Medical Branch- khaghani st- shariati Ave- Tehran- Iran
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2260 1934
Email
hashemian.f@iaups.ac.ir
Web page address
http://www.iautmu.ac.ir/research/index.asp
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Sahenalzamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
6th Floor, IAU Central Organization, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 1601
Email
m_szamani@iautmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Sahebalzamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
6th Floor, IAU Central Organization, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 2281 1045
Fax
Email
m_szamani@iautmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Sahebalzamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
6th Floor, IAU Central Organization, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran, I.R.Iran.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 1601
Email
m_szamani@iautmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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