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Completed

NCT Number: NCT04118335

Mulberry Syrup on Oral Mucositis Healing

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.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. Duration of oral mucositis healing

    Time frame: Change from oral mucositis healing levels at 15 days

    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.

Secondary outcomes

  1. Severity of oral mucositis

    Time frame: Change from severity of oral mucositis at 15 days

    Severity of oral mucositis were evaluated with World Health Organization Oral Mucositis Scoring Index by examining the patients mucous membrane with the help of light source and asking patients.

    World Health Organization Oral Mucositis Scoring Index: According to this index, the severity of oral mucositis is graded as grade 0; no mucositis, grade 1; mild, grade 2; moderate, grade 3-4; severe mucositis.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 8, 2019
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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