Determining the effect of nursing care based on Orlando's theory on preoperative anxiety and adherence to treatment in patients undergoing mastectomy.
Design
The clinical trial has an intervention group and a control group with 44 subjects, which will be selected in simple randomization by lottery. There is no blindness in this study.
Settings and conduct
This research will be carried out on patients undergoing mastectomy in the surgical department at Faqihi Hospital in Shiraz. The subjects of this research are 44 patients selected during hospitalization. The interventions include: preoperative training, giving the patients the opportunity to express their feelings and answering the patients questions.
Participants/Inclusion and exclusion criteria
The study participants are: women with breast cancer at the Shiraz Faqihi hospital, waiting for simple mastectomy, between 20 and 55 years old and have an anxiety score above 15. Participants with learning difficulties and a history of breast surgery subjects will be exclude from the study.
Intervention groups
Nursing care in the intervention group based on Orlando’s theory: patients’ needs are assessed through a 30-45-minute communication. At the beginning of the meeting with patients, the investigator asks questions about their knowledge about mastectomy and feelings towards the operation. This interactive process will be continuing based on the patient's answers and responding accordingly to the needs of patients. For the control group, only the usual interventions will be carried out, which include: serum therapy, giving medication as directed by the doctor, sedation if needed and checking for vital signs, are carried out.
Main outcome variables
Anxiety and adherence to treatment of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240219061049N1
Registration date:2024-05-02, 1403/02/13
Registration timing:registered_while_recruiting
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Arezoo Behzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 1190
Email address
a.behzadi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing care based on Orlando's theory on anxiety and adherence to treatment in patients undergoing mastectomy
Public title
The effect of nursing care based on Orlando's theory in patients undergoing mastectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with an anxiety score greater than 15 (moderate to severe anxiety level) according to the Beck's questionnaire
Patients undergoing simple mastectomy
Obtaining permission from the patient's doctor
Age between 20 to 55 years
Willingness and awareness to participate in the research
Ability to read and write in Persian language
Exclusion criteria:
History of breast surgery
Learning problems such as Alzheimer
Mental illness such as anxiety and depression
Acute physical diseases
Cancer metastasis to other organs
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be selected according to the inclusion criteria during hospitalization for mastectomy. Then, they will be allocated to the control or intervention groups through simple random allocation by lottery. In this method, the investigator considers one card as the first group (A = symbol of the intervention group) and the other card for the second group (B = symbol of the control group). Then, by merging the cards together, one card will come out, which indicates whether that subject belongs to the intervention or control group. In fact, this lottery will be done individually for each subject.
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 Jahrom University of Medical Sciences
Street address
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2024-02-19, 1402/11/30
Ethics committee reference number
IR.JUMS.RES.1402.125
Health conditions studied
1
Description of health condition studied
Examining anxiety and adherence to treatment after the implementation of Orlando's theory in women with breast cancer who are waiting for mastectomy.
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of breast
Primary outcomes
1
Description
Anxiety levels in Beck's questionnaire
Timepoint
before and immediately after the intervention.
Method of measurement
Measuring anxiety by Beck's anxiety questionnaire.
Secondary outcomes
1
Description
The score obtained from the Medanlo treatment adherence questionnaire
Timepoint
Before and one month after the intervention
Method of measurement
Questionnaire for adherence to treatment of medanlo
Intervention groups
1
Description
Intervention group: the researcher will start the intervention with a 30-45 minute meeting. According to Orlando's theory, the researcher begins to talk to patients and check their needs, through asking questions about their knowledge about mastectomy and feelings towards the operation. The continuation of this interactive process is based on the patient's answers. The researcher's response to the patient's verbal and non-verbal behaviors include explanations about mastectomy, its benefits and complications, type of anesthesia and post-operative care. Then she shows to the patient real pictures from the entrance of operating room and surgical equipment. She teaches the patient relaxation techniques such as deep breathing skills and answers the patient's possible questions, and if necessary, talks with the patient's family to reduce the patient's anxiety level. Other actions will be performed according to the patient's needs.
Category
Other
2
Description
For the control group, only the usual interventions will be carried out, which include: serum therapy, administering prescribed medications, giving sedation if needed and checking vital signs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid faqihi hospital
Full name of responsible person
Zohre badiyepeyma jahromy
Street address
Faqihi Hospital, Zand St., Shiraz, Fars ,Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Amir abdoli
Street address
Faculty of nursing, jahrom University of medical sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
Pazhuheshi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Zohre badiyepeyma jahromy
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
z.badiyepeyma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Zohre badiyepeyma jahromy
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
Behzadiarezoo2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of the subjects these items are not shared.
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
The data that are going to be available will be discussed in chapters four and five of the thesis and finally a brief explanation of them will be given in the article extracted from thesis.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
access for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To publish articles and scientific references
From where data/document is obtainable
Jahrom University of Medical Sciences, Dr. Zohra Badiyepeyma Jahrom.
What processes are involved for a request to access data/document
In order to obtain the required data, dear researchers can send an email to Dr. Zohra Badiye Peyma at z.badiyepeyma@gmail.com, which will be answered within 14 days.