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

The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery on Family-centered Care Perception and Anxiety: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Children; Parents; Education; Day Surgery; Family-centered Care
• Intervention / Treatment: Other: education

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sevinc Akkoyun, Phd; Phone Number: +9003322231090; Email: sevincakkoyun87@gmail.com

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42060
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experiment; 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.	Other: education; 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.
No Intervention: control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety level	parents' anxiety levels	1 day before and after
Perception of family-centered care level	Parents' perception of family-centered care	1 day before and after

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Director: Fatma Tas Arslan, professor, Selcuk University; Study Director: Tamer Sekmenli, associate professor, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; children; education; Parents; day surgery; family-centered care
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021/46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No