Does the Level of Pain in Pediatric Oncology Patients Affect the Level of Psychological Resilience in Parents?

June 5, 2024 updated by: Bahar Nur Kanbur, Istanbul Gelisim University
Resilience is defined as generating coping strategies for the problems and situations that individuals face throughout their lives and developing these strategies in each new situation. While some individuals become helpless in the face of difficulties and give up the struggle, other individuals recover quickly in the face of difficulties and use coping methods well. Accordingly, these individuals have higher levels of crisis management and coping with stress.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Psychological resilience is defined as the process of adaptation, the power of recovery or the ability to successfully overcome change/disasters against significant sources of stress such as a trauma, a threat, a tragedy or family and relational distress, serious health problems, workplace and financial problems. At the same time, psychological resilience, as a personality trait, is also used to mean the power to recover quickly, the power to overcome difficulties, resilience, flexibility and robustness. Individuals who are successful in repairing the psychological destruction that occurs as a result of negative emotional states are considered to be strong individuals in terms of psychological resilience.

Identification of protective factors Psychological resilience is a dynamic process resulting from the interaction of risk factors and protective factors. In the literature, the most frequently emphasized characteristics when defining psychological resilience are risk factors, protective factors that mitigate the impact of negative events and adaptation to risk factors.

Personal risk factors include anxious temperament, health problems, lack of self-confidence, inability to use effective coping mechanisms, inability to express oneself effectively, aggressive personality, pessimistic perspective.

Familial risk factors include lack of healthy family relationships, domestic violence, loss of parents, neglect and abuse in the family, and negative relationships.

Environmental risk factors include low socio-economic level, lack of positive role models, unemployment and migration.

Protective factors are situations that increase the individual's adaptation to all risk factors and improve the individual's competencies. In other words, they are factors that reduce or eliminate the negative effects of risk factors. In research, risk factors and protective factors are analyzed in three stages: individual, familial and environmental It is stated that individuals with high levels of psychological resilience have a higher level of control over their behaviors compared to other individuals, believe that they can achieve higher success as a result of their efforts, have better social competence and responsibilities, and are more successful in solving problems. When we look at other characteristics of individuals with high psychological resilience, it is stated that they have the power and resilience to influence the people around them and to take advantage of upsetting events and to achieve results. It has also been found that individuals with high levels of resilience have high levels of self-confidence and less anxiety. These individuals like to struggle and do not like to give up. Individuals with low levels of psychological resilience have poor self-control capacity, withdraw from the environment, do not participate in social life and show resistance to change. Individuals with good resilience prefer to struggle by questioning their lives.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Avcılar
      • Istanbul, Avcılar, Turkey
        • İstanbul Gelişim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will consist of children between the ages of 4-18 and their parents who are being treated at the Oncology Clinic of Altınbaş University Medical Park Bahçelievler Hospital in Istanbul.

Description

Inclusion Criteria:

  • Children will be between 4-18 years old
  • Communicable children and families
  • The child will be hospitalized for inpatient treatment

Exclusion Criteria:

  • Outpatients
  • Terminal patients
  • Children whose parents cannot be reached will be excluded from work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychological resilience scale
Time Frame: 2 day
The pain level of the child receiving chemotherapy will reduce the psychological resilience of the mother. In the schematic evaluation, the scoring method is free for measuring psychological resilience as high or low.
2 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Gelisim University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebru Sevinç, Arel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Istanbul Gelişim Üniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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