NCT05668416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

December 3, 2022

Last Update Submit

September 4, 2023

Conditions

Keywords

Parentseducationchildrenday surgeryfamily-centered careAnxiety

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

experiment

EXPERIMENTAL

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

control

NO INTERVENTION

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.

Interventions

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.

experiment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of children with day surgery
  • Parents who speak and understand Turkish
  • Parents who volunteered to participate in the study

You may not qualify if:

  • Parents of children who have had elective surgery
  • Parents of children who have had previous surgery
  • Parents with mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

  • Akkoyun S, Arslan FT, Sekmenli T. The effect of written document in perioperative information on the anxiety level and family-centered care of parents of children undergoing ambulatory surgery: A randomized controlled trial. J Pediatr Nurs. 2024 Mar-Apr;75:108-115. doi: 10.1016/j.pedn.2023.12.012. Epub 2023 Dec 25.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Fatma Tas Arslan, professor

    Selcuk University

    STUDY DIRECTOR
  • Tamer Sekmenli, associate professor

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: It is a randomized controlled trial. In this parallel group study, intervention group and control group will take place.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer (Phd)

Study Record Dates

First Submitted

December 3, 2022

First Posted

December 29, 2022

Study Start

December 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 15, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The effect of the education given to the parents of the children who will undergo day surgery.

Shared Documents
STUDY PROTOCOL
Time Frame
December 2022-March 2023 (3 months)

Locations