[A psychological burden on patients with clinical trials during anesthesia].
We investigated with questionnaires, psychological outline of 30 patients, who were requested to participate in clinical trials of anti-tachycardia drugs during anesthesia. Although 14 patients consented to the trial, the consent was not based on adequate understanding or volunteerism in 3 patients. Nine patients of the consented group were anxious about the possible use of the trial drug. Eight patients of the rejected group felt anxiety on surgery and anesthesia, which was the most common reason for rejection. Forty % of refused patients felt a guilty conscience or embarrassed. Although we tried to obtain patients' consent following governmental and institutional regulations and guidelines, not only the consented but also the refused patients suffer from psychological burden with the clinical trial. It is of concern that recruitment to the trial enhances anxiety of the patients as they already feel uneasiness, unrest, and insecurity facing anesthesia and surgery. To avoid entry of less informed or unwilling patients to the clinical trial, we must secure patients' veto, and recruitment should be performed by clinicians who are not involved in anesthesia practice.
Otsuka
H
H
Department of Anesthesiology, Hokkaido University School of Medicine, Sapporo.
Niida
Y
Y
Numazawa
R
R
Hashimoto
T
T
Hasebe
N
N
Kemmotsu
O
O
D000758:Anesthesia / Q000523:psychology*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001007:Anxiety; D002986:Clinical Trials as Topic / Q000523:psychology*; D006801:Humans; D007431:Intraoperative Complications / Q000188:drug therapy; D018579:Patient Selection; D013514:Surgical Procedures, Operative / Q000523:psychology*; D011795:Surveys and Questionnaires; D013610:Tachycardia / Q000188:drug therapy; D016312:Treatment Refusal
D000889:Anti-Arrhythmia Agents