Application of Auricular Point Sticking in Patients With Taste Alteration

NCT05868850 | Completed

• 1 other identifier: 1415322141
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the intervention effect of auricular point sticking on chemotherapy-induced taste alterations in cancer patients, and analyze its relationship with quality of life, nutritional status and psychology of patients.

Conditions

Dysgeusia; Acupressure; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Taste alterations

  The Chinese version of the Chemotherapy-induced Taste Alteration Scale (CiTAS), was used to assess the patients' taste alterations. The scale has 18 items in three dimensions, namely taste alteration, unpleasant taste alteration, unpleasant symptoms and problems. The scale is a Like-5 scale with a minimum score of 18 and a maximum score of 90, with higher scores indicating more severe symptoms of taste alterations. The scale has been verified by research and has good reliability and validity.

  T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks.

Secondary Outcomes (6)

• Quality of life for cancer patients

  T1: Baseline. T2:2 weeks. T3: 4 weeks. T4:5 weeks. T5:8 weeks.

• Anxiety and depression

  T1: Baseline. T2:2 weeks. T3:4 weeks. T4:5 weeks. T5:8 weeks.

• Nutritional status 1

  T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

• Nutritional status 2

  T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

• Nutritional status 3

  T1: baseline(Data were collected before the intervention). T2: 4 weeks. T3:8 weeks.

Study Arms (2)

Routine care group

NO INTERVENTION

The control group receives routine nursing, including admission education, routine nursing of adverse reactions to chemotherapy, diet guidance for chemotherapy patients, precautions for various examinations, discharge guidance and follow-up.

Auricular point sticking group

EXPERIMENTAL

Auricular point sticking therapy is performed on the basis of control group. The acupoint intervention group is established, and the research team consists of 2 graduate students, 1 graduate supervisor, 1 head nurse, 1 chief physician of traditional Chinese medicine, and 1 nursing expert. The nursing expert is responsible for the overall design of the project, and the director of traditional Chinese medicine is responsible for the selection of acupoints and the training of nurses for massage. The supervisor of graduate students and the head nurse are responsible for the overall quality control of the intervention process, while the graduate students are responsible for the preliminary and final screening of research objects, the implementation of intervention programs, the organization, coordination and recording of the entire intervention process and the collection of data.

Behavioral: auricular point sticking

Interventions

auricular point sticking BEHAVIORAL

1. Acupoint selection: Select Shenmen, spleen, stomach, liver, sympathetic, tongue, digestive system under the cortex, three focal, ear-back spleen. 2. Operation: Use 75% ethanol to disinfect auricular broad skin; To be dry, use tweezers to pick up the middle of the small square tape stuck with Wang do not line seeds, align the indentation and stick well, press gently with the finger abdomen, the strength to the patient feel acid swelling, pain and heat sense and can tolerate it. 3. Press frequency and course of treatment: it is asked to press 4 times a day, once in the morning, middle and evening before going to bed, 3-5 minutes each time, the duration of hospitalization for patients with chemotherapy is generally 3-5 days, intervention begins on the first day of chemotherapy medication, the day of discharge for patients to replace the other side of the ear acupoint, removed after 4 days of discharge. A total of 2 chemotherapy courses were treated.

Auricular point sticking group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant tumors diagnosed by histopathology or pathology;
• Age ≥18 years old;
• Patients who received platinum-based chemotherapy and completed at least one cycle of chemotherapy;
• According to the chemotherapy-induced taste Changes Scale (CiTAS), the score of patients was ≥6;
• Patients voluntarily participated in the treatment with good compliance and adherence.

You may not qualify if:

• Patients with treatment plan adjustment or concurrent radiotherapy;
• Patients with abnormal taste and malnutrition caused by various reasons before chemotherapy;
• Patients with inflammation of the external ear or eczema, ulcers, chilblain in the pressing area;
• Allergic or intolerant to adhesive stickers;
• Those who were lost to follow-up or withdrew voluntarily;
• Patients enrolled in other studies at the same time.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Quan Liu, Doctor

  Affiliated Hospital of Jiangnan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 22, 2023
• Study Start: June 3, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)