PainNCT06445816
Does the Level of Pain in Pediatric Oncology Patients Affect the Level of Psychological Resilience in Parents?
An observational study of Pain and Pediatric Oncology, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pain, Pediatric Oncology, Psychological Resilience
- What is being tested?
- chemotherapy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children will be between 4-18 years old
- Communicable children and families
- The child will be hospitalized for inpatient treatment
Who cannot join
- Outpatients
- Terminal patients
- Children whose parents cannot be reached will be excluded from work
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Pediatric Oncology, Psychological Resilience
- Being tested
- chemotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
- Parents whose consent was obtained will be asked to fill out the Mother and Child Information Collection Form and Psychological Resilience Scale, respectively.
- Immediately after receiving chemotherapy, the pain levels of the children will be measured with the Facial Expressions Pain Scale - Faces Pain Scale-Revised (FPS-R).
- The psychological resilience scale will be applied to mothers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological resilience scale
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.
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Nur Kanbur, Istanbul Gelisim University
- Investigators
- Ebru Sevinç, Principal investigator, Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445816
- Sponsor's protocol ID
- Istanbul Gelişim Üniversity
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Level of Pain in Pediatric Oncology Patients Affect the Level of Psychological Resilience in Parents?
- ClinicalTrials.gov ID
- NCT06445816
- Acronym / sponsor ID
- Istanbul Gelişim Üniversity
- Conditions
- Pain, Pediatric Oncology, Psychological Resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 Jun 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children will be between 4-18 years old
- Communicable children and families
- The child will be hospitalized for inpatient treatment
Key exclusion criteria (3 listed)
- Outpatients
- Terminal patients
- Children whose parents cannot be reached will be excluded from work
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 |
|---|---|---|
| chemotherapy* Parents whose consent was obtained will be asked to fill out the Mother and Child Information Collection Form and Psychological Resilience Scale, respectively. * Immediately after receiving chemotherapy, the pain levels of the children will be measured with the Facial Expressions Pain Scale - Faces Pain Scale-Revised (FPS-R). * The psychological resilience scale will be applied to mothers. | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Ebru Sevinç principal investigator
Arel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pediatric Oncology, run by Istanbul Gelisim University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Psychological resilience scale (time frame: 2 day). 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 6 Jun 2024.