This research aimed to compare the effect of preoperative training approach by nurse and peer on women's anxiety undergoing ovarian puncture. This is a non-blinded randomized clinical trial. The participants were the ovarian puncture candidates aged 18-45 who visited Yazd Infertility Center, Iran. After convenience sampling, the participants were assigned into three groups (Nurse Training, Peer Training, and Control) through block randomization method. There were 70 participants in each group. The two-part questionnaire (Demographic and Spielberger) will be completed at the time of admission. Then, two training groups received training prior to the surgery. Anxiety Questionnaire was completed immediately before going to the operation room and before discharge by all three groups. Training was as follows:
In the lecture method, a nurse and a trained peer provided the patients with discussions, questions, and answers for 30 to 60 minutes after they filled out the admission anxiety questionnaire. The peer in this study had already passed the necessary trainings about the content of the training program in two sessions by the same nurse in order to unify the educational content in the two groups. The samples of the control group didn’t receive any preoperative training. According to the routine practices of the ward, the samples received postoperative care training by the ward nurse for 30 minutes after surgery.
The main outcome in this study was anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010331753N1
Registration date:2017-06-30, 1396/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Atharah Kalantari
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 259 0449
Email address
a.kalantari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Yazd University of Medical Sciences.
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pre-operative training by nurse and peer on the anxiety of women undergoing ovarian puncture.
Public title
Comparison of two method of preoperative training on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
Ovarian puncture candidate; be Willing to participate in the study; Patients at the age of 18-45 years; Communicating in Persian Language; Being Literate.
Exclusion Criteria:
Mental illness؛ addiction؛ cancer؛ Anti-anxiety drug intake 24 hours before the surgery؛ The experience of acute postoperative complications such as bleeding, shock, and transfer to the ICU؛ oocyte donor.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The method of randomization in this study is block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.SSU.REC.1395.202
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
generalized anxiety disorder
2
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Anxiety.
Timepoint
Baseline, preoperative, before discharge.
Method of measurement
Spielberger questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Preoperative training by a nurse: through the lecture method, a nurse provides the patients with discussions, questions, and answers during 30 to 60 minutes after they fill out the admission anxiety questionnaire. The content is comprised of description of the type of surgery (based on patient’s medical record), patient transfer time to the operating room, approximate duration of surgery, introduction of non-pharmacological stress reduction techniques such as deep breath, postoperative diet, how to take medications, side effects of medications, quality and amount of sleep, and postoperative physical activity.
Category
Prevention
2
Description
Preoperative training by a peer: through the lecture method, a trained peer provides the patients with discussions, questions, and answers during 30 to 60 minutes after they fill out the admission anxiety questionnaire. The peer in this study has already passed the necessary trainings about the content of the training program in two sessions by the same nurse in order to unify the content in the two groups. The content is comprised of description of the type of surgery (based on patient’s medical record), patient transfer time to the operating room, approximate duration of surgery, introduction of non-pharmacological stress reduction techniques such as deep breath, postoperative diet, how to take medications, side effects of medications, quality and amount of sleep, and postoperative physical activity. In addition, the peer shares his/her personal experience and the positive experience of his/her acquaintances or peers.
Category
Prevention
3
Description
The samples of the control group do not receive any preoperative training. The preoperative admission questionnaire is filled out. According to the routine practices on the ward, the samples receive postoperative care training by the ward nurse for 30 minutes after surgery, and then the pre-discharge anxiety questionnaire is filled out. This training program is implemented for all three groups in a similar way before discharge
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproduction Sciences Institute
Full name of responsible person
Atharah Kalantari
Street address
Bouali avenue, timsar falahi street, Yazd.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yazd University of Medical Sciences
Full name of responsible person
Ms. Morshedyan
Street address
Yazd University of Medical Sciences, Bahonar Square
City
yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Atharah Kalantari
Position
Master Student in Nursing
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh, Yazd
City
Yazd
Postal code
Phone
+98 35 3525 2291
Fax
Email
a.kalantari@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Farnia
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Bouali Ave, Timsar Falahi street
City
Yazd
Postal code
Phone
+98 35 3824 5777
Fax
Email
farnia@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atharah Kalantari
Position
Master student in nursing
Other areas of specialty/work
Street address
Bouali Ave, Timsar falahi street
City
Yazd
Postal code
Phone
+98 35 3525 2291
Fax
Email
a.kalantari@ssu.ac.ir; kalantariathara@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)