NCT07126054

Brief Summary

This study aimed to evaluate the effects of bibliotherapy administered to adolescent patients in the preoperative period on vital signs, anxiety levels, and coping attitudes using a pretest-posttest controlled experimental design. The main hypotheses: H1: Bibliotherapy administered to adolescent patients during the preoperative period positively affects at least one of the patients' vital signs. H2: Bibliotherapy administered to adolescent patients during the preoperative period reduces the patients' state anxiety level. H3: Bibliotherapy administered to adolescent patients during the preoperative period reduces the patients' trait anxiety level. H4: Bibliotherapy administered to adolescent patients during the preoperative period increases the patients' level of coping with illness. Researchers will compare control group to see if vital signs, anxiety and coping with illnes levels. Bibliotherapy was applied to the intervention group, while the control group received routine clinical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 9, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Adolescent patientperioperative periodbibliotherapycoping with illnessanxiety

Outcome Measures

Primary Outcomes (7)

  • Vital sign: pulse

    Pulse is the rhythmic expansion of an artery caused by the ejection of blood from the heart, reflecting the heart rate and rhythm.

    Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)

  • Vital sign: blood pressure

    Blood pressure is the force exerted by circulating blood against the walls of the arteries, indicating the pressure during heartbeats (systolic) and between beats (diastolic). Ask ChatGPT Blood pressure is the force exerted by circulating blood against the walls of the arteries, indicating the pressure during heartbeats (systolic) and between beats (diastolic). Ask ChatGPT Blood pressure is the force exerted by circulating blood against the walls of the arteries, indicating the pressure during heartbeats (systolic) and between beats (diastolic).

    Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)

  • vital sign: body temperature

    Body temperature is the measure of the body's ability to generate and dissipate heat, reflecting the balance between heat production and heat loss.

    Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)

  • vital sign: respiratory rate

    Breathing, or respiratory rate, is the number of breaths taken per minute, indicating how effectively the body is exchanging oxygen and carbon dioxide.

    Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)

  • vital sign: Oxygen saturation

    Oxygen saturation is the percentage of hemoglobin in the blood that is saturated with oxygen, indicating how efficiently oxygen is being transported to body tissues.

    Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)

  • State-Trait Anxiety Inventory for Children

    The State-Trait Anxiety Inventory for Children measures both the temporary (state) and general (trait) levels of anxiety experienced by children. The highest possible score on the State Anxiety Inventory is 60, and the lowest is 20. An increase in the score indicates a higher level of anxiety.

    Day 1: 1 hour after the decision for surgery is explained to the patient and and at after eigth hours from surgery (Day 1)

  • Coping Attitudes Assessment Scale

    The Coping Attitudes Assessment Scale evaluates an individual's strategies and attitudes toward managing stress and adapting to challenging situations. The highest possible score on the scale is 160, and the lowest is 40. A higher score on the scale indicates a higher level of coping attitude.

    Day 1: 1 hour after the decision for surgery is explained to the patient and and at after eigth hours from surgery (Day 1)

Study Arms (2)

Intervention group

EXPERIMENTAL

As part of the bibliotherapy intervention, the book "My Surgery Journey" (bibliotherapy), developed by the researchers, was read to the patients during in two hours the preoperative period and discussed individually with them, aiming to help the patients understand the surgical process and reduce their anxiety.

Behavioral: bibliotherapy

Control group

NO INTERVENTION

Only routine nursing care and information were continued in this group.

Interventions

bibliotherapyBEHAVIORAL

Bibliotherapy is a therapeutic approach that uses carefully prepared reading materials (My Surgery Story) to support individuals' understanding, coping, and anxiety, facilitated through guided reading and discussion.

Intervention group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • who were between 10 and 17 years old,
  • literate (able to read and write),
  • diagnosed with appendicitis and scheduled for surgery,
  • without any prior major surgical interventions,
  • who, along with their parents, consented to participate in the study.

You may not qualify if:

  • Failure of the patient to recover physiologically on the 1st and 2nd postoperative days
  • Presence of postoperative complications
  • Early discharge from the clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medipol University Hospital

Istanbul, Bağcılar, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersCritical Illness

Interventions

Bibliotherapy

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant masking indicates a patient with a diagnosis of chronic renal failure receiving hemodialysis treatment
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a pretest-posttest randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 17, 2025

Study Start

October 1, 2023

Primary Completion

January 30, 2024

Study Completion

June 1, 2024

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) collected in this study, including de-identified demographic information, clinical measurements (vital signs), anxiety scores, and coping assessment results, will be made available to other qualified researchers upon reasonable request. All shared data will be fully anonymized to protect participant confidentiality. Data will be accessible starting from \[12 months\] after publication of the primary results, through a secure data repository or via direct request to the corresponding author. Researchers requesting access will be required to submit a brief proposal outlining the purpose of the data use and agree to data use agreements ensuring ethical and secure handling of the information.

Locations