Clinical trial NCT04118335: Mulberry Syrup on Oral Mucositis Healing
Official title: The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Oral mucositis in COPD patients
complementary therapies
nursing interventions
oral care with black mulberry syrup
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.

Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.

Detailed description: Objective: This mix study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.

Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. Approval from the Ethics Committee and written permission from the institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age,
* no visual or hearing problem,
* unimpaired time and place orientation,
* no psychiatric disorders,
* diagnosed with COPD,
* oral mucositis developed,
* used Nystatin and/or Benzidamine Hydrochloride therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Duration of oral mucositis healing
timeFrame: Change from oral mucositis healing levels at 15 days
Secondary outcomes:
measure: Severity of oral mucositis
timeFrame: Change from severity of oral mucositis at 15 days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Sevda Korkut, PhD
role: PRINCIPAL_INVESTIGATOR
References: