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The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery

Primary Purpose

Parents, Education, Children

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
education
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parents focused on measuring Parents, education, children, day surgery, family-centered care, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Parents of children with day surgery Parents who speak and understand Turkish Parents who volunteered to participate in the study Exclusion Criteria: Parents of children who have had elective surgery Parents of children who have had previous surgery Parents with mental health problems

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experiment

control

Arm Description

The intervention group will include parents who were trained in the preoperative period. The training includes brochures and oral training prepared by the researchers in line with the literature and the training given in the hospital.

The control group will be the oral information group that is in the hospital routine. Parents in this group will be informed verbally when they come to the hospital for anesthesia and file procedures the day before the surgery.

Outcomes

Primary Outcome Measures

anxiety level
parents' anxiety levels
Perception of family-centered care level
Parents' perception of family-centered care

Secondary Outcome Measures

Full Information

First Posted
December 3, 2022
Last Updated
September 4, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05668416
Brief Title
The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery
Official Title
The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery on Family-centered Care Perception and Anxiety: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parents, Education, Children, Day Surgery, Family-centered Care, Anxiety
Keywords
Parents, education, children, day surgery, family-centered care, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized controlled trial. In this parallel group study, intervention group and control group will take place.
Masking
Participant
Masking Description
Single (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experiment
Arm Type
Experimental
Arm Description
The intervention group will include parents who were trained in the preoperative period. The training includes brochures and oral training prepared by the researchers in line with the literature and the training given in the hospital.
Arm Title
control
Arm Type
No Intervention
Arm Description
The control group will be the oral information group that is in the hospital routine. Parents in this group will be informed verbally when they come to the hospital for anesthesia and file procedures the day before the surgery.
Intervention Type
Other
Intervention Name(s)
education
Intervention Description
The training includes brochures and oral training prepared by the researchers in line with the literature and the training given in the hospital. Education brochure (Day surgery training brochure); An educational brochure was prepared by the researchers in line with the literature and practices in the institution. The brochure was composed of 3 sections: pre-operative, on the day of the operation and after the operation.
Primary Outcome Measure Information:
Title
anxiety level
Description
parents' anxiety levels
Time Frame
1 day before and after
Title
Perception of family-centered care level
Description
Parents' perception of family-centered care
Time Frame
1 day before and after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parents of children with day surgery Parents who speak and understand Turkish Parents who volunteered to participate in the study Exclusion Criteria: Parents of children who have had elective surgery Parents of children who have had previous surgery Parents with mental health problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tamer Sekmenli, associate professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The effect of the education given to the parents of the children who will undergo day surgery.
IPD Sharing Time Frame
December 2022-March 2023 (3 months)

Learn more about this trial

The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery

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