This Study Aimed to Determine the Effect of Guided Imagery on Anxiety, Depression and Side effects of Chemotherapy in Cancer Patients. A Sample of 70 Eligible Cancer Patients Enrolled in two groups (26 patients in each group). Inclusion Criteria Including being in 20 years and older And Exclusion Criteria Including Having Anxiety or Depression Disorders. Patients in the Intervention Group listen to the Audio-Recorded Guided Imagery Scripts.Patients in The Control Group Received Only Chemotherapy Primary Outcomes: It is Expected that Guided Imagery will be Effective on the level of Anxiety, Depression and Severity of Side Effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101924919N3
Registration date:2016-11-22, 1395/09/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-22, 1395/09/02
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Guided Imagery on Anxiety, Depression and Side Effects of Chemotherapy in Cancer Patients
Public title
Effect of Guided Imagery on Anxiety, Depression and Side Effects of Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
The Inclusion Criteria Included being in 20 years and older; Ability to Communicate with the Persian language; Received Chemotherapy in the first Period.
Exclusion Criteria Included Having Anxiety or Depression disorders; Experiencing severe and emergency Complications of Chemotherapy.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Pardize Oloompezashki, Haft Bagh e Alavi
City
Kerman
Postal code
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
Ir.kmu.res.1395.118
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
c80
ICD-10 code description
Malignant neoplasm, without specification of site
Primary outcomes
1
Description
Anxiety
Timepoint
Before Intervention and before pass next Chemotherapy Session
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
2
Description
Depression
Timepoint
Before Intervention and before pass next Chemotherapy Session
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Secondary outcomes
1
Description
Side Effects
Timepoint
Before Intervention and before pass next Chemotherapy Session
Method of measurement
Symptom Distress Scale (SDS)
Intervention groups
1
Description
Patients in The Intervention Group listen to the Audio-Recorded Guided Imagery Scripts.
Category
Behavior
2
Description
Patients in The Control Group Received Only Chemotherapy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Service and Therapy Centers of kerman
Full name of responsible person
Kambiz Bahaaddini Ph.D
Street address
22 Bahman High Way
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty Ph.D
Street address
Pardize Oloompezeshki, Haft Bagh e Alavi
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Javad Mahdizadeh
Position
Master of Degree Student in Medical Surgical Nursing
Other areas of specialty/work
Street address
Pardize Oloompezeshki, Haft Bagh e Alavi
City
Kerman
Postal code
Phone
+98 343433315652
Fax
Email
mahdizadeh.4014@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgary Ph.D
Position
Nursing Ph.D
Other areas of specialty/work
Street address
Pardize Oloompezeshki, Haft Bagh e Alavi
City
Kerman
Postal code
Phone
+98 34 3132 5207
Fax
Email
Batool.Tirgary@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Javad Mahdizadeh
Position
Master of Degree Student in Medical Surgical Nursing
Other areas of specialty/work
Street address
Pardize Oloompezeshki, Haft Bagh e Alavi
City
Kerman
Postal code
Phone
+98 34 3331 5652
Fax
Email
Mahdizadeh.4014@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)