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Comparison of the effect of receiving and not-receiving supportive-educational intervention on the level of stress, depression, anxiety, perceived social support, and satisfaction of the caregivers of the patients undergoing gynecological surgery; a randomized clinical trial

Protocol summary

Summary
The aim of the current study is to comparative evaluation of the effect of receiving and not-receiving supportive, educational intervention on the level of stress, depression, perceived social support, and satisfaction of the caregivers of the patients undergoing gynecological surgery. The research population is the patients’ caregivers referring to Khorramabad city’s training Asali hospital. The number of the subjects regarding to sample size formula is 60 caregivers in each group. The caregivers will be classified in 2 groups; control group (without supportive, educational intervention), and intervention group (with supportive, educational intervention). In intervention group, each caregiver will be undergone education and support in time of her patient’s arrival to the operating theater after obtaining informed consent form and directing to the waiting room located beside the operating theater according to the predetermined supportive educational program, but control group will not receive any supportive educational intervention. Before and after the patient’s surgery, the level of the stress, anxiety, and depression of the caregivers will be assessed by depression, anxiety and stress scale(DASS21), the level of satisfaction by self made questionnaire and perceived social support by the Multidimensional Scale of Perceived Social Support, respectively. The subjects and study statistician are not informed about the groups and the way of delivering intervention. The inclusion criteria are the following; lack of psychological disease, being of patient’s caregiver in the hospital and in the waiting room during surgery; being literate. The exclusion criteria are the following: lack of desire to continue cooperation in each step of the study and/or the decease of the patient.

General information

Acronym
depression, anxiety and stress scale, DASS
IRCT registration information
IRCT registration number: IRCT201604205596N5
Registration date: 2016-07-01, 1395/04/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Nasrin Galehdar
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 66142099714
Email address
galehdar.n@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan University of Medical Sciences and Vice chancellor for research of Lorestan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of receiving and not-receiving supportive-educational intervention on the level of stress, depression, anxiety, perceived social support, and satisfaction of the caregivers of the patients undergoing gynecological surgery; a randomized clinical trial
Public title
Effect of supportive-educational intervention on the level of stress, depression, anxiety, perceived social support, and satisfaction of the caregivers of the patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Desire to participate in the study; ability to perceive and fill out the questionnaire; lack of psychological disease; the age between 18 to 55 years old; lack of participation in current similar study; being of patient caregiver in the hospital and waiting room in time of surgery; being literate. Exclusion criteria: Lack of desire to continue cooperation in each step of the study; decease of the patient.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is performed using random numbers table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan
City
Khorramabad
Postal code
Approval date
2015-04-06, 1394/01/17
Ethics committee reference number
LUMS.REC.1394.2

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

2

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

3

Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

4

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

5

Description of health condition studied
Perceived social support
ICD-10 code
-
ICD-10 code description

Primary outcomes

1

Description
The level of depression, anxiety and stress of the caregivers
Timepoint
Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater
Method of measurement
Depression, Anxiety and stress scale(DASS21)

Secondary outcomes

1

Description
The level of satisfaction
Timepoint
Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater
Method of measurement
The self made questionnaire

2

Description
Perceived social support
Timepoint
Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater
Method of measurement
The multidimensional scale perceived social support

Intervention groups

1

Description
The patients’ caregivers being in the waiting room will be presented via supportive educational program by operating theater nurse in form of speech, question and answer, and slides by a monitor. This international program will be in 6 steps, and each step will take 10 minutes long. The educational points will be about postoperative cares; the principles and arrangements of traffic and visit; correct and effective communication. The necessary information will be presented to the patient’s caregiver in educational programs intervals. Each caregiver will be visited by operating theater nurse to receive support and answers of the questions sporadically for at least 10 minutes.
Category
Other

2

Description
The control group will receive no education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital of Khorramabad city
Full name of responsible person
Nasrin Galehdar
Street address
Asali khorramabad charity hospital, Palestine street, Khorramabad, Lorestan
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Morovat Taheri Kalani
Street address
Lorestan University of Medical Sciences, Academic Complex Kamalvand, kilometer 5 khorramabad road Tehran, Khorramabad, Lorestan
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nemat Bakhsh
Street address
Azadi square, Hezar Jarib avenue, 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
Isfahan University of Medical Sciences
Proportion provided by this source
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
Lorestan University of Medical Sciences
Full name of responsible person
Nasrin Galehdar
Position
MSc of nursing education, Faculty member
Other areas of specialty/work
Street address
Paramedical faculty, Goldasht, Khorramabad, Lorestan
City
Khorramabad
Postal code
Phone
+98 66 3340 9971
Fax
Email
galehdar.n@lums.ac.ir; galehdr_nas@yahoo.co.in
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Nasrin Galehdar
Position
MSc of nursing education, Faculty member
Other areas of specialty/work
Street address
Paramedical faculty, Goldasht, Khorramabad, Lorestan
City
Khorramabad
Postal code
Phone
+98 66 3340 9971
Fax
Email
galehdar.n@lums.ac.ir; galehdr_nas@yahoo.co.in
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Nasrin Galehdar
Position
MSc of nursing education, Faculty Member
Other areas of specialty/work
Street address
Paramedical faculty, Goldasht, Khorramabad, Lorestan
City
Khorramabad
Postal code
Phone
+98 66 3340 9971
Fax
Email
galehdar.n@lums.ac.ir; galehdr_nas@yahoo.co.in
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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