Psycho-educationalBibliotherapyNCT07126054
The Effect of Bibliotherapy Administered During the Preoperative Period on Vital Signs, Anxiety, and Coping With Illness in Adolescent Patients
A study testing bibliotherapy in people with Psycho-educational and Anxiety, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Psycho-educational, Anxiety, Illness, Critical
- What is being tested?
- bibliotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Failure of the patient to recover physiologically on the 1st and 2nd postoperative days
- Presence of postoperative complications
- Early discharge from the clinic
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medipol University Hospital
Istanbul, Bağcılar
Istanbul Medipol University
Istanbul
About this study
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.
Read more
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.
Read the detailed description
The study was conducted with 90 adolescent patients scheduled for surgical intervention at the pediatric surgery clinic of a city hospital. Data were collected using the "Personal Information Form," "Vital Signs Monitoring Form," "State-Trait Anxiety Inventory for Children," and the "Coping Attitudes Assessment Scale. In the intervention group, a three-stage process (pre-test, bibliotherapy, and post-test) was implemented; as part of bibliotherapy, the book "My Surgery Journey" was read to the patients and discussed individually to help them understand the surgical process and reduce anxiety. In the control group, only pre-test and post-test measurements were conducted at the same time intervals, without any psychoeducational intervention. In both groups, vital signs, anxiety levels, and coping with illness were assessed using standardized scales and measurement methods.
- Conditions
- Psycho-educational, Anxiety, Illness, Critical
- Being tested
- bibliotherapy
- Keywords
- Adolescent patient, perioperative period, bibliotherapy, coping with illness, anxiety
- Medical subject headings
- Anxiety Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bibliotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: bibliotherapy |
| Control group | No intervention | Only routine nursing care and information were continued in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1: 1 hour after the decision for surgery is explained to the patient and and at after eigth hours from surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2023
- Primary completion30 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psycho-educationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a pretest-posttest randomized controlled experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pınar dogan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126054
- Sponsor's protocol ID
- 98127364
- Acronym
- Bibliotherapy
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bibliotherapy Administered During the Preoperative Period on Vital Signs, Anxiety, and Coping With Illness in Adolescent Patients
- ClinicalTrials.gov ID
- NCT07126054
- Acronym / sponsor ID
- Bibliotherapy / 98127364
- Conditions
- Psycho-educational, Anxiety, Illness, Critical
- Keywords
- Adolescent patient, perioperative period, bibliotherapy, coping with illness, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted with 90 adolescent patients scheduled for surgical intervention at the pediatric surgery clinic of a city hospital. Data were collected using the "Personal Information Form," "Vital Signs Monitoring Form," "State-Trait Anxiety Inventory for Children," and the "Coping Attitudes Assessment Scale. In the intervention group, a three-stage process (pre-test, bibliotherapy, and post-test) was implemented; as part of bibliotherapy, the book "My Surgery Journey" was read to the patients and discussed individually to help them understand the surgical process and reduce anxiety. In the control group, only pre-test and post-test measurements were conducted at the same time intervals, without any psychoeducational intervention. In both groups, vital signs, anxiety levels, and coping with illness were assessed using standardized scales and measurement methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a pretest-posttest randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: bibliotherapyAs 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. |
| Control group | No intervention | –Only routine nursing care and information were continued in this group. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Failure of the patient to recover physiologically on the 1st and 2nd postoperative days
- Presence of postoperative complications
- Early discharge from the clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bibliotherapyBibliotherapy 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. | Behavioural | Intervention group |
Primary outcome
Vital sign: pulse
Time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)
Pulse is the rhythmic expansion of an artery caused by the ejection of blood from the heart, reflecting the heart rate and rhythm.
Vital sign: blood pressure
Time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)
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).
vital sign: body temperature
Time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)
Body temperature is the measure of the body's ability to generate and dissipate heat, reflecting the balance between heat production and heat loss.
vital sign: respiratory rate
Time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)
Breathing, or respiratory rate, is the number of breaths taken per minute, indicating how effectively the body is exchanging oxygen and carbon dioxide.
vital sign: Oxygen saturation
Time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)
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.
State-Trait Anxiety Inventory for Children
Time frame: Day 1: 1 hour after the decision for surgery is explained to the patient and and at after eigth hours from surgery (Day 1)
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.
Coping Attitudes Assessment Scale
Time frame: Day 1: 1 hour after the decision for surgery is explained to the patient and and at after eigth hours from surgery (Day 1)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bibliotherapy in people with Psycho-educational and Anxiety, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital sign: pulse (time frame: Day 1: Before two hours from surgery and at after eigth hours from surgery (Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.