Comparison of the effect of providing health information, based on client's needs and based on nurse's diagnosis, on the anxiety of family members of cancer patients
Design
Pre and post-test intervention research and phase 3. with parallel groups, on 40 first-degree family members of cancer patients, randomization at first by targeted method and then by minimization based on classes of anxiety and education
Settings and conduct
This study will be conducted in Ali Ibn Abitalib Hospital and Arsen Clinic in Rafsanjan. Family members of cancer patients will be provided with health information based on their needs. For the second group, health information will be identified during the nurse's interactions and based on the nurse's diagnosis. The anxiety score of the samples in the two groups before and after the intervention will be determined through the Spielberger situational anxiety questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria:First-degree family members of all patients with cancer in Rafsanjan in the age range of 18-75 years and diagnosed with cancer in the last 6 months, who have at least a high school diploma, sufficient cognitive ability to answer questions and obtain a moderate to high anxiety score from the Spielberger Situational Anxiety Scale.ٍExclusion criteria: Having a history of mental illness or addiction and unfortunate events in the last 6 months and the occurrence of circumstances that force one to leave the question and answer with the nurse.
Intervention groups
Intervention group 1: Providing cancer-related health information based on the needs of family members of cancer patients.Intervention group 2: health information related to cancer will be identified during the nurse's interactions and the required information will be provided in different areas based on the nurse's diagnosis.
Main outcome variables
Anxiety state
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230611058452N1
Registration date:2023-07-29, 1402/05/07
Registration timing:retrospective
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Fatemeh Kianifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0000
Email address
kianifarfatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2022-11-22, 1401/09/01
Actual recruitment end date
2023-01-31, 1401/11/11
Trial completion date
2023-01-31, 1401/11/11
Scientific title
Comparison the effect of providing health information, based on client needs and nurse diagnosis, on anxiety of family members of cancer patients
Public title
Investigating the effect of providing health information on family members anxiety of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18-75 years
Patients who have been diagnosed with cancer in the last 6 months
Having at least a diploma in literacy
Having sufficient cognitive ability for questioning and answering
Being a first degree family member (father, mother, child, sibling and spouse)
Provide written informed consent to participate in the study
Getting a moderate to high anxiety score from the Spielberger situational anxiety scale
Exclusion criteria:
Having a known mental illness or addiction
Experiencing any adverse events in the past 6 months
Occurrence of circumstances that force you to leave questions and answers with the nurse
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Minimization method: Allocation of the first Subjectin each class in one of the study groups will be by random drawing through a sealed envelope. The second sample with the same characteristic will be assigned to the next group in the same class.
Blinding (investigator's opinion)
Single blinded
Blinding description
The anxiety score of the samples in the two groups before and after the intervention will be determined through the Spielberger situational anxiety questionnaire by a researcher associate who does not know how to allocate the samples in the groups, by face-to-face interview method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-07-30, 1401/05/08
Ethics committee reference number
IR.RUMS.REC.1401.092
Health conditions studied
1
Description of health condition studied
The effect of providing cancer related health information on the anxiety of family members of cancer patients
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
The level of anxiety States
Timepoint
Before and after the intervention
Method of measurement
Spielberger state anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: For this group, information related to various health aspects of cancer patients will be provided by the nurse based on the needs and requests expressed by their family members.
Category
Other
2
Description
Intervention group2: For the second group, cancer-related health information was identified during the nurse's interactions and based on the nurse's diagnosis, the information needed in different areas such as the nature of cancer, diagnostic methods, treatment methods, disease process, disease consequences, treatment complications and disease recurrence symptoms, acceptance of the disease by the patient and family, recognition of symptoms that require immediate intervention, recognition of the psychological changes of patients in response to cancer, emotional support, proper relationship with the patient, nutrition, rehabilitation at home and the level of patients' activities and return to Normal life activities will be provided.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital
Full name of responsible person
Fatemeh Kianifar
Street address
Ali Ibn Abitalib square, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
Kianifarfatemeh@gmail.com
2
Recruitment center
Name of recruitment center
Arsen Clinic
Full name of responsible person
Fatemeh Kianifar
Street address
Zeytoon Blvd
City
Rafsanjan
Province
Kerman
Postal code
7719756383
Phone
+98 34 3424 2452
Email
Kianifarfatemeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Street address
Faculty of Nursing and Midwifery, Parastar Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
negahbant@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Parastar Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
negahbant@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Parastar Blvrd
City
rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
negahbant@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Kianifar
Position
Ms.Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Parastar Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
kianifarf@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
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