An interventional study of Press needle acupuncture and Plesterin in Pediatric Cancer, Chemotherapy-induced Nausea and Vomiting and Chemotherapy Effect, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Indonesia University · Not applicable, Interventional, and Prevention
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 64 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
The control group was given a placebo press needle acupuncture (using plaster) with standard medical therapy for CINV prevention.
Device: Plesterin
The intervention group was given press needle acupuncture with standard medical therapy for CINV prevention.
Device: Press needle acupuncture
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.
The plaster used is a round plaster that resembles the shape of an acupuncture press needle.
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
Method instrument for assessing nausea and vomiting consisting of eight statements
Time frame: 9 days
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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