Clinical Trial: Farming, Personal Protective Equipment, Nepal
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of Farmers' Exposure to Pesticides With Relevant Personal Protective Equipment in Chitwan District of Nepal
Brief Summary: According to the World Health Organization pesticide poisoning is a major health problem due to the millions of cases annually occurring worldwide. Farmers have a particularly high risk of pesticide poisoning because of their work involving pesticide use to protect crops. The majority of pesticide poisonings occur in developing countries. On a short term it is not realistic to reduce farmers' use of pesticides significantly because it would require that secure and cost-effective alternatives are introduced. This is a lengthy process, which should undoubtedly be supported. However, it becomes as important to make sure that farmers can protect themselves from pesticide exposure meanwhile. Use of personal protective equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their risk of pesticide poisoning. However, the sparse research identified through a systematic literature review shows that we are not in a position to give recommendations on what personal protective equipment farmers should protect themselves with against pesticide exposure suitable to their specific conditions. The purpose of the present study is to examine factors that influence farmers' use of personal protective equipment during their work with organophosphates and, based on this examine the ability of locally adapted personal protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers working in locally adapted personal protective equipment have less acute organophosphate poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible solution than farmers working in their daily practice wearing. Examining how locally adapted personal protective equipment (onwards referred to as the LAPPE solution) performs in practice implies testing it in an intervention study. A randomized crossover experiment design is chosen partly because fewer farmers have to be recruited since each farmer will act as his own contro
Detailed Summary:
LITERATURE SEARCH STRATEGY:
Based on recommendations from information specialists in the field of health, agriculture and technology the following databases were chosen to search for scientific literature about the present study's purpose: Pubmed, Embase, SveMed, CAB abstracts (Centre for Agriculture and Biosciences International), Agris, DADS (Denmark's Technical University's Digital Library), Scopus and Ebsco. The key search terms for the literature search were: personal protective equipment, farmers, pesticides, developing countries and tropical climate. Synonyms for each of these search terms were identified by means of Gyldendals Dictionary and previous international literature. In Pubmed, SveMed, Embase, CAB abstracts and Agris the synonyms were applied to find subject headings which the main search was based on. However, in DADS, Scopus, Ebsco searches on subject headings was not an option and therefore the main search was based on the synonyms.
- Pubmed: 3349 hits, subject headings for key terms personal protective equipment and pesticides with no limitations.
- Embase: 399 hits, subject headings for key terms personal protective equipment and pesticides with the limitation human.
- SveMed: 24 hits, subject headings for key terms personal protective equipment and pesticides.
- CAB abstracts: 607 hits, subject headings for key terms personal protective equipment and pesticides.
- Agris: 681 hits, subject headings for key terms personal protective equipment and pesticides.
- DADS 8650 hits, subject headings for key terms personal protective equipment and pesticides.
- Scopus: 1988 hits, synony
Sponsor: Bispebjerg Hospital
Current Primary Outcome: Plasma Cholinesterase [ Time Frame: Farmers will be followed over 15 days (cholinesterase measured four times) ]
Plasma cholinesterase is a substance necessary for the proper functioning of the human nervous system. The inhibition of this type of cholinesterase is considered as a useful indicator of exposure to organophosphates when measured before and after likely exposure. Plasma cholinesterase will be measured with a Test-mate Cholinesterase System (Model 400) requiring 10 microliters (µL) for a blood test.
Original Primary Outcome: Same as current
Current Secondary Outcome: Acute Organophosphate Poisoning Symptoms [ Time Frame: Farmers will be followed for 15 days (symptoms measured four times) ]
The World Health Organization has constructed a clinical representation of acute organophosphate poisoning consisting of: headache, dizziness, bradycardia, weakness, anxiety, excessive sweating, fasciculations, abdominal cramps, dyspnea, miosis, paralysis, salivation, tearing, ataxia, pulmonary edema, vomiting, diarrhea, confusion, acetyl cholinesterase inhibition. In the present study, all clinical representations except from acetyl cholinesterase inhibition will be evaluated as self-reported acute organophosphate poisoning symptoms. However, some of the clinical representations may be difficult for the farmers' to report themselves and therefore such clinical representations have been translated into more understandable terms. Furthermore, symptoms are added based on local health care experience. In a survey information on self-reported acute organophosphate poisoning symptoms will be retrieved with yes/no response options as has been seen in previous studies.
Original Secondary Outcome: Acute Organophosphate Poisoning Symptoms [ Time Frame: Farmers will be followed for 15 days (symptoms measured four times) ]
The World Health Organization has constructed a clinical representation of acute organophosphate poisoning consisting of: headache, dizziness, bradycardia, weakness, anxiety, excessive sweating, fasciculations, abdominal cramps, dyspnea, miosis, paralysis, salivation, tearing, ataxia, pulmonary edema, vomiting, diarrhea, confusion, acetyl cholinesterase inhibition. In the present study, all clinical representations except from acetyl cholinesterase inhibition will be evaluated as self-reported acute organophosphate poisoning symptoms. However, some of the clinical representations may be difficult for the farmers' to report themselves and therefore such clinical representations have been translated into more understandable terms. In a survey information on self-reported acute organophosphate poisoning symptoms will be retrieved with the question: "Do you have any of the following symptoms?" with yes/no response options as has been seen in previous studies.
Information By: Bispebjerg Hospital
Dates:
Date Received: May 7, 2014
Date Started: August 2014
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015
