The Effect of Oral Care Protocol on Prevention of Oral Mucositis in

Status Completed

Clinical Trial Summary

This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.

Clinical Trial Description

The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis. The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups. In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors." Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used. The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04586491
Study type	Interventional
Source	Dokuz Eylul University
Contact
Status	Completed
Phase	N/A
Start date	October 7, 2019
Completion date	February 10, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04262830` - Cancer Therapy Effects on the Heart
Not yet recruiting	`NCT06335745` - PediCARE Health Equity Intervention in High-Risk Neuroblastoma	N/A
Withdrawn	`NCT04719416` - Relaxation Therapy in Pediatric Oncology	N/A
Completed	`NCT01645436` - Physical Activity in Pediatric Cancer (PAPEC)	N/A
Completed	`NCT04409301` - Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation	N/A
Completed	`NCT04914702` - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting	`NCT05425043` - Granulocyte Transfusions After Umbilical Cord Blood Transplant	N/A
Recruiting	`NCT05071859` - Genetic Overlap Between Anomalies and Cancer in Kids in the Children's Oncology Group: The COG GOBACK Study
Recruiting	`NCT03241251` - Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
Recruiting	`NCT05384288` - Response to Influenza Vaccination in Pediatric Oncology Patients
Recruiting	`NCT05569512` - Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML	Phase 1/Phase 2
Enrolling by invitation	`NCT05294380` - Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
Completed	`NCT02675166` - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Completed	`NCT02665819` - Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility.	N/A
Not yet recruiting	`NCT05454163` - Post-radiotherapy Rhinosinusitis in Children
Terminated	`NCT02536183` - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors	Phase 1
Withdrawn	`NCT01828502` - Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer	Phase 2
Completed	`NCT02032121` - Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors	N/A
Completed	`NCT03964259` - Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia	Phase 1
Recruiting	`NCT05851625` - Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms