Mulberry Syrup on Oral Mucositis Healing

NCT04118335 | Completed

• 1 other identifier: 2017/42
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Oral mucositis in COPD patients; complementary therapies; nursing interventions; oral care with black mulberry syrup

Outcome Measures

Primary Outcomes (1)

• Duration of oral mucositis healing

  Oral mucosa of patients were evaluated with The Oral Evaluation Guide by examining the patients mucous membrane with the help of light source and asking patients. Oral Evaluation Guide: The guideline evaluates the changes of the oral mucosa in eight areas. In the evaluation of the guide, numerical expressions like 1, 2, 3 are used and the changes in voice, swallowing function, saliva, tongue, lips, mucous membranes, gums, teeth or prostheses are scored. When scoring, all scores from eight areas are collected and the Oral Mucosal Score (OMS) is calculated. The lowest possible score is 8 and the highest score is 24. As the score increases, intra-oral complaints and the severity of mucositis increase.

  Change from oral mucositis healing levels at 15 days

Secondary Outcomes (1)

• Severity of oral mucositis

  Change from severity of oral mucositis at 15 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

The individuals in the intervention group were asked to gargle with 5 ml black mulberry syrup three times a day after meals and wait average one minute in the mouth and then swallow, in addition to the standard practice of the clinic. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. The patients were followed for 15 days. The 15-day period is consistent with the duration of mucositis healing in the literature. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.

Other: Black Mulberry Syrup

Control Group

NO INTERVENTION

Standard procedures of the clinic were applied to control group. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.

Interventions

Black Mulberry Syrup OTHER

The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sevda Korkut, PhD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: March 9, 2017
• Primary Completion: March 9, 2017
• Study Completion: June 28, 2018
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)