Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Cancer Pain

Pain

Neurologic Manifestations

Quality of Life

The intervention group was give a press needle acupuncture with standard medical therapy for gynecological cancer pain

The control group was given standard medical therapy for gynecological cancer pain

Ear acupuncture using Pyonex press needles were installed with a diameter of 0.17mm, 0.9mm deep. The needles were retained for three days and stimulated at the installation site of the patch needle by means of pressure on the acupuncture point ears that have been attached needles on both sides, 1 minute at each point, four times a day, for 3 consecutive days and the patch was removed on the 3rd day

Press Needle Acupuncture

KEPK FKUI-RSCM

Pain is one of the most important symptoms of cancer patients, with nearly 40% of all cancer patients experiencing moderate to severe pain. Gynecological oncology patients on palliative care have a chief complaint of pain or significant nausea/vomiting, contrary to the patient's initial complaints on admission such as fever, infection, dyspnea, changes, altered consciousness, bleeding, pancytopenia. Strong recommendations by WHO regarding the use of non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol and opioids either alone or in combination in adults, including the elderly and adolescents with cancer-related pain in the early stages, pain relief depending on clinical judgment and severity to achieve pain treatment which is fast and safe. Ear acupuncture is a simple and safe method that can be used alone or in combination with other forms of medical care, which is effective in treating a variety of conditions as well as painful conditions. Based on the previous 2020 systematic review regarding ear acupuncture in its benefits in cancer pain, it was stated that ear acupuncture was effective in treating pain in cancer patients with moderate pain levels, effective for reducing pain scores, faster onset, and longer duration of analgesics. Ear acupuncture is also more effective when compared to standard therapy without acupuncture, so it can be used as an additional modality for cancer pain. Currently there is no research on the effectiveness of BFA ear acupuncture therapy in the treatment of gynecological cancer pain to treat it based on the consistency of point selection, so it is necessary to conduct research on the effectiveness of BFA ear acupuncture therapy in the treatment of gynecological cancer pain.

This study aim to analyze the effectiveness of BFA ear acupuncture therapy plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (EORTC QLQ C-30 score) in patients with gynecological cancer pain compared to standard therapy alone.

This study was conducted using a single blinded randomized control clinical trial design in 58 female patients who are hospitalized aged 18-65 years, have a diagnosis of gynecological cancer, with a VAS score≥4 caused by tumor, before or during a therapeutic process (radiation therapy, chemotherapy, or after surgery), agree to participate in the study, sign the informed consent form who were randomized into 2 groups, namely group I BFA ear acupuncture with standard therapy and group 2 standard therapy, the acupuncture points used were placed at points MA-IT1 Cingulate Gyrus, MA-AT2 Thalamus, MA-H2 Omega 2, MA-H1 Point Zero, MA-TF1 Shenmen on both sides of the ear using Pyonex needles were placed with a diameter of 0.17mm, depth of 0.9mm. the pyonex press needle. were retained for three days The outcome assessed were pain intensity using the VAS, changes in analgesic dose, and quality of life with the EORTC QLQ C-30 questionnaire, which was assessed on the day before starting therapy, the first day, the second day, the third day, the fifth day and the seventh day

The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain

The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy Compared With Standard Therapy in Gynecological Cancer Pain

Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.

assessment used to assess intensity of certain sensations and feelings, like pain.

European Organisation for Research and Treatment of Cancer Quality of Life C30, that include two item of review functional scale and the global health scale both scale the higher the score the outcome will be better

Analgetic used during the treatment measured in miligram

Indonesia University

Medical Doctor

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Breast Diseases

Skin Diseases

Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Ear acupuncture

Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.

Psychoeducation

Gustav Dobos, Prof. MD

The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. It will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved. In addition, a proinflammatory cytokine will be meassured.

Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer

Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial

Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate. The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis. The question whether a bed-partner or roommate is present is not included in qualitative analysis as well. The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction). Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale. The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality. A cut-off score of 5 indicates a "poor" sleeper.

Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

Hospital Anxiety and Depression Scale (HADS). It measures the 2 dimensions anxiety and depression. Scores range from 0 to 21 with higher values indicate higher distress. Values of \>8 indicate potential subclinical anxiety or depressive disorders.

Perceived Stress Scale (PSS). Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale. For the summed items (range from 0 to 40) a higher total score indicates greater stress.

Number of patients with adverse events and type of the adverse event

Visual Analogue Scale (VAS). The Visual Analogue Scale is a continuous measurement device on which the degree of agreement is indicated by a cross between two end points. We define the end points of the Visual Analalogue Scale for expectations concerning treatment as "expecting the treatment to be not sucessfull at al" and "expecting the treatment to be extremely successful.

Karl and Veronica Carstens Foundation

Universität Duisburg-Essen

Nausea

Vomiting

Signs and Symptoms, Digestive

The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.

The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Press needle acupuncture

The plaster used is a round plaster that resembles the shape of an acupuncture press needle.

Plesterin

Wahyuningsih Djaali

Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.

The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.

Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients

Method instrument for assessing nausea and vomiting consisting of eight statements

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain	NCT06115330	Gynecologycal C... Cancer Related ... Cancer Pain	Press Needle Ac...	18 Years - 65 Years	Indonesia University
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain	NCT06115330	Gynecologycal C... Cancer Related ... Cancer Pain	Press Needle Ac...	18 Years - 65 Years	Indonesia University
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen
The Effectiveness of Battlefield Acupuncture (BFA) With Standard Therapy in Gynecological Cancer Pain	NCT06115330	Gynecologycal C... Cancer Related ... Cancer Pain	Press Needle Ac...	18 Years - 65 Years	Indonesia University
Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients	NCT05851625	Pediatric Cance... Chemotherapy-in... Chemotherapy Ef...	Press needle ac... Plesterin	6 Years - 18 Years	Indonesia University

Spots Global Cancer Trial Database for ear acupuncture