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To evaluate the impact of stage assessment nursing mode on the psychological state of healthy participants in Phase I clinical trials of new drugs based on psychological questionnaire.
This was a randomized, single blind, controlled clinical research. Healthy participants were randomly divided into treatment and control group. According to the impact of anxiety and depression on healthy participants, the treatment group was given a stage evaluation nursing model, while the control group received routine nursing measures. Both groups were evaluated using the self rating depression scale (SDS) and self rating anxiety scale (SAS) questionnaires before administration, on the day of administration, after administration (mid-term of the trial), on the day of discharge, and on the day of withdrawal, and their effectiveness was observed.
A total of 159 healthy participants were included in the study, with 83 cases in the treatment group and 76 cases in the control group. SDS scores of treatment group and control group were (54.93±4.62) and (54.87±4.89) points before administration, (52.17±6.55) and (53.95±7.03) points on the administration day, (49.94±7.35) and (51.69±9.16) points at the mid-term of the trial, (52.13±6.70) and (53.85±6.76) points on the discharge day, (51.33±7.99) and (52.60±7.39) points on the day of withdrawal, respectively. Compared with before administration, there was statistically significant difference in treatment group during administration day and the day of withdrawal, as well as in the mid-term of trial in the control group (all P<0.01). SAS scores for treatment group and control group were (36.08±6.45) and (37.04±6.87) points before administration, (36.18±7.79) and (37.43±8.53) points on administration day, (35.04±7.09) and (36.86±9.55) points at the mid-term of the trial, (35.82±7.75) and (37.68±8.78) points on discharge day, (39.29±9.17) and (36.47±7.91) points on the day of withdrawal, respectively. No statistical significance of SAS scores was observed (all P>0.05).
Use of psychological questionnaires and stage nursing assessment forms for evaluation and nursing intervention can alleviate the levels of depression and anxiety in healthy participants.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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