Assessing the effect of peer awareness on preoperative anxiety of a candidate for thyroidectomy
Design
A clinical trial with a control group with parallel groups, without blinding, randomized on 78 patients, the blocking method was used for randomization.
Settings and conduct
This study is performed in Imam Khomeini Hospital of Tehran. First, the background and demographic information of the patients were collected. before awareness Patients complete Spielberger Manifest Anxiety Questionnaire and the saliva sample taken. then, in the intervention group, awareness is performed and the next day saliva samples taken and Patients complete Questionnaire again. The control group receives the information according to the previous routine of the ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ages 18 to 70; First surgical experience; Lack of family relationship with other participants in the study; No family history of thyroidectomy; No membership in the treatment team; Lack of speech and hearing problems; No dementia and cognitive impairment; Do not take medications that reduce or increase cortisol (such as corticosteroids, anticonvulsants, insulin).
Exclusion criteria:
Any severe changes and worsening of the disease during the study; Any invasive treatment during the study; Any patient dissatisfaction during the project.
Intervention groups
In the intervention group, guidance including patient health and surgery information and postoperative care, thyroidectomy complications and other information is provided to the patients in the intervention group in a 30 minute session.
Main outcome variables
Anxiety before thyroidectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201206049623N1
Registration date:2021-02-12, 1399/11/24
Registration timing:registered_while_recruiting
Last update:2021-02-12, 1399/11/24
Update count:0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
atefe asadpurasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3235 1775
Email address
a-asadpurasl@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pre-operative provision of information with Peer method on anxiety of patients undergoing thyroidectomy surgery
Public title
Effect of pre-operative provision of information with Peer method on anxiety of patients before thyroidectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 70
First surgical experience
Lack of family relationship with other participants in the study
No family history of Thyroidectomy
Not be part of the medical staff
Lack of speech and hearing problems
No dementia and cognitive impairment
Do not take medications that reduce or increase Cortisol (such as Corticosteroids, Anticonvulsants, Insulin)
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research is done in two stages. In the first step, the samples are selected by the Convenience Sampling method. In the second stage, the allocation of samples to the two groups of intervention and control is done randomly and by blocking method; The letter A is considered for the intervention group and the letter B for the control group. Then we write all the combinations of the letters A, A, and B ,B, which are 6 different combinations, on 6 cards: 1. AABB 2. ABBA 3. ABAB 4. BAAB 5. BABA 6. BBAA Then, from digits 1 to 6, a digit is randomly selected( With the help of a table of random numbers or patient number one is asked to choose a card at random.) For example, if the digit 2 is selected This means that the first person is in the intervention group and the next two people are in the control group and the fourth person is in the intervention group and This Process continues until the sample size reaches the quorum.
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
School of Nursing and Midwifery and School of Rehabilitation, Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417935840
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.TUMS.FNM.REC.1399.146
Health conditions studied
1
Description of health condition studied
thyroidectomy surgery
ICD-10 code
E00–E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score in Spielberger's overt anxiety questionnaire
Timepoint
Completion of the questionnaire before the intervention and after informing
Method of measurement
Spielberger Obvious Anxiety Questionnaire
2
Description
Measuring anxiety with salivary cortisol levels
Timepoint
Before the intervention and one day after provision of information
Method of measurement
Saliva sample in the amount of 3 to 5 cc
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, guidance including patient health and surgery information and postoperative care, thyroidectomy complications and other information is provided to the patients in the intervention group in a 30-minute session. It should be noted that the peer groups in this study are those who have recently undergone surgery and have a drain and dressing in the neck area. To reduce errors due to peer diversity, peers are taught by the researcher about postoperative complications, symptoms of calcium loss, swallowing and voice changes, cervical drainage, and psychological support. At the end of the training, a checklist is prepared that And its reliability has been pre-measured and evaluated by the researcher. The answers to the clients' questions are also done by the researcher.
Category
Other
2
Description
Control group: The control group receives routine ward training by nurse.