Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05668416 |
| Other study ID # |
2021/46 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
February 15, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Selcuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to examine the effect of the preoperative education given to the
parents of the children who will undergo day surgery on the parents' perception of
family-centered care and anxiety.
It is a randomized controlled trial. In this parallel group study, intervention group and
control group will take place. The research will be carried out in the pediatric surgery
service of the Selcuk University Medical Faculty Hospital. A total of 60 parents, including
the intervention group (n=30) and the control group (n=30), will be included in the study.
Parents to be included in the study will be assigned to intervention and control groups by
randomization method. The randomization will be hidden from the researcher conducting the
trial until the administration begins. The researcher will be given 60 envelopes and will
begin to open the envelopes when he meets the parent. The researcher will learn which group
each parent is in just before the application. Data collection tools; information form, state
anxiety scale and Family Centered Care Assessment Scale. During the data collection phase,
the purpose of the research will be explained to the parents by the researcher, information
about the study will be given and consent will be obtained from the parents who agreed to
participate in the research through the "Informed Voluntary Consent Form". A brochure
prepared in line with the literature and the training given in the hospital will be given to
the initiative group and verbal information will be given. On the other hand, only verbal
information will be given to the control group, which is done in the hospital routine. The
contents of the brochure include Preparation at Home 1 Day Before the Day of Surgery,
Preparation at the Hospital on the Day of Surgery, and Home Care After the Surgery. Brochure
and information will be given to the intervention group in the polyclinic one day before the
surgery. Information Form, State Anxiety Scale and Family Centered Care Evaluation Scale will
be filled in the polyclinic. The Information Form will be filled with the information
obtained from the parents and the patient file. State Anxiety Scale and Family Centered Care
Assessment Scale will be filled during discharge. Data will be analyzed with the IBM SPSS 22
(IBM Corporation, New York, NY) program. Partial eta squared will be calculated for the
effect size and the significance level will be accepted as p<0.05.
Description:
The aim of the study is to examine the effect of the preoperative education given to the
parents of the children who will undergo day surgery on the parents' perception of
family-centered care and anxiety.
It is a randomized controlled trial. In this parallel group study, intervention group and
control group will take place. The research will be carried out in the pediatric surgery
service of the Selcuk University Medical Faculty Hospital. The sample size of our study was
determined by G-Power analysis. The analysis was determined as 24 parents (48 in total) in
each group with 95% confidence interval, 0.05 margin of error, 1.08 effect size, 0.95 power.
Data losses (25%) were also taken into account and 30 parents (60 in total) were determined
for each group. Inclusion criteria; (a) Parents of children who had outpatient surgery, (b)
Parents who can speak and understand Turkish, (c) Parents who volunteered to participate in
the study. Exclusion criteria: (a) Parents of children who had elective surgery, (b) Parents
of children who had previous surgery, (c) Parents with mental health problemsA total of 60
parents, including the intervention group (n=30) and the control group (n=30), will be
included in the study. Parents to be included in the study will be assigned to intervention
and control groups by randomization method. Control and intervention groups will be assigned
by an independent statistician to reduce selection bias and control for variables that may
affect the results. The randomization will be hidden from the researcher conducting the trial
until the administration begins. The researcher will be given 60 envelopes and will begin to
open the envelopes when he meets the parent. The researcher will learn which group each
parent is in just before the application. Data collection tools; information form, state
anxiety scale and Family Centered Care Assessment Scale. During the data collection phase,
the purpose of the research will be explained to the parents by the researcher, information
about the study will be given and consent will be obtained from the parents who agreed to
participate in the research through the "Informed Voluntary Consent Form". A brochure
prepared in line with the literature and the training given in the hospital will be given to
the initiative group and verbal information will be given. On the other hand, only verbal
information will be given to the control group, which is done in the hospital routine. The
contents of the brochure include Preparation at Home 1 Day Before the Day of Surgery,
Preparation at the Hospital on the Day of Surgery, and Home Care After the Surgery. Brochure
and information will be given to the intervention group in the polyclinic one day before the
surgery. Information Form, State Anxiety Scale and Family Centered Care Evaluation Scale will
be filled in the polyclinic. The Information Form will be filled with the information
obtained from the parents and the patient file. State Anxiety Scale and Family Centered Care
Assessment Scale will be filled during discharge. Data will be analyzed with the IBM SPSS 22
(IBM Corporation, New York, NY) program. Partial eta squared will be calculated for the
effect size and the significance level will be accepted as p<0.05.
