Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT05668416
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2022-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Education Given to Parents of Children Undergoing Outpatient Surgery
Sponsor:
Selcuk University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: