The effects of discharge plan on stress,anxiety and depression in patients undergoing percutaneous transluminal coronary angioplasty in hospitals affiliated to shiraz university of medical science
This is a randomized control trail which was planned to determine the effects of discharge planning on the stress, anxiety,and depression of those undergone the angioplasty of coronary artery.
The inclusion criteria contain age limit of 30 to 70, lack of psychological disorders and psychological therapy on the basis of a psychologist advice, lack of any types of cognitive, speech and hearing disorders. Moreover, the exclusion criteria are the incidence of sharp deterioration or worsening ailment for each subject during the survey.Based on randomized control method, 80 candidates of angioplasty who had the inclusion criteria were classified into control and experimental groups. The instruments for data collection were a demographic questionnaire and a stress, anxiety and depression questionnaire (DASS-21).
participants of control group received the usual treatment while the patients in the experimental group took part in two training sessions before and after the procedure. They were also provided a follow-up on the phone once a week in two weeks time after their discharge. The questionnaires were completed by both the control and experimental subjects at admission, discharge and a month after their discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302182812N12
Registration date:2013-09-07, 1392/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of discharge plan on stress,anxiety and depression in patients undergoing percutaneous transluminal coronary angioplasty in hospitals affiliated to shiraz university of medical science
Public title
The effects of discharge plan on stress,anxiety and depression in patients undergoing percutaneous transluminal coronary angioplasty in hospitals affiliated to shiraz university of medical science
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Age limit of 30 to 70; Lack of psychological disorder and psychological therapy on the basis of a psychologist advice; Lack of previous angioplasty; Lack of any types of cognitive, speech and hearing disorders; Access to telephone; A complete consent to participate in the survey.
Exclusion criteria:The incidence of sharp deterioration in the ailment.; The elimination of those who face critical conditions during the survey; The elimination of those who are not willing to keep taking part in the survey.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
1
Registry name
--------
Secondary trial Id
----------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Central building, Zand St
City
Shiraz
Postal code
713451978
Approval date
2012-12-24, 1391/10/04
Ethics committee reference number
CT-91-6353
Health conditions studied
1
Description of health condition studied
coronary heart disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
anxiety
Timepoint
time of the addmission, discharge and a month after their discharge.
Method of measurement
stress,anxiety.depression questionnar DASS-21
2
Description
Stress
Timepoint
time of the addmission, discharge and a month after their discharge.
Method of measurement
stress,anxiety.depression questionnar DASS-21
3
Description
Depression
Timepoint
time of the addmission, discharge and a month after their discharge.
Method of measurement
stress,anxiety.depression questionnar DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
participants of control group received routine oral instructions: to be NPO, to shave, and how to take the drugs. And after angioplasty, at discharge, they also received a pamphlet on diet, amount of activities, and incidence of pain and bleeding.
Category
Other
2
Description
Patients in the experimental group participated in a 30-minute training session about the reason of angioplasty, its procedures, and the required equipment for angioplasty, and the events occurring at angioplasty. At discharge, they received a booklet about the necessity of changes in the life style such as doing exercises, giving up smoking, stress and anxiety control and relaxation, amount of activities, diet, taken drugs and their side effects, when and how to have sexual activity, taking care of the incision and its pain, necessary actions in case of bleeding and/or hematoma, referral of symptoms, and also necessity of participation in cardiac rehabilitation program. These subjects were explained to the patients and a family member, face-to-face, in a forty-minute session.They,also were followed up on the phone once a week in two weeks time immediately after discharge.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr Farkhondeh Sharif
Street address
Namazi hospital, Namazi Square, Zand street,
City
shiraz
2
Recruitment center
Name of recruitment center
Shahid Dr. Faghihi Hospital
Full name of responsible person
Dr Farkhondeh Sharif
Street address
Zand Avenue, Shahid Dr. Faghihi Hospital
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DrGholamreza Hatam
Street address
Shiraz University of Medical Sciences,University Central Building,Zand street, beside red cross
City
SHIRAZ
Grant name
Grant code / Reference number
CT-91-6353
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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 Sciences,
Full name of responsible person
Farkhondeh Sharif
Position
ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, ZAND Street, University central building, Next to Red Cresent Shiraz
City
shiraz
Postal code
713451359
Phone
+98 71171121222401
Fax
Email
fsharif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farkhondeh sharif
Position
ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Central building, Zan
City
shiraz
Postal code
713451359
Phone
+98 71121222401
Fax
Email
fsharif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)