Akiko Mori1. 1. St Luke's College of Nursing - Research Center for Development of Nursing Practice, 3-8-5, Tsukiji Chuo-ku, Tokyo 104-0045, Japan. akiko-mori@slcn.ac.jp
Abstract
AIM: The purpose of this study was to determine the effects of a support program for the stress management of women undergoing fertility treatment to reduce stress related to infertility and treatment. METHODS: We randomly assigned seven institutions into an experimental group (four institutions, n = 96) and a control group (three institutions, n = 44) using cluster randomization. The women in the experimental group were asked to continue stress management homework for 3 months. A nurse provided feedback on the homework every month. Those in the control group were given only the booklet. The primary outcomes were the risk ratios of "depression" and "anxiety" according to the Hospital Anxiety and Depression Scale. The secondary outcomes were "health status" from the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) v2 and "satisfaction" from the Visual Analogue Scale. We excluded 15 women who became pregnant and performed an intention-to-treat analysis of 125 women. RESULTS: There were no differences in the incidence of depression and anxiety between the experimental and control groups. There were significant interaction effects between the program and time in the scores of the two subscales of SF-36 and the summary. There was no difference in satisfaction. The use of ovulation-enhancing agents showed that the scores of "role functioning physical" and "physical component summary" in the non-use subgroup were higher at 2 and 3 months in the experimental group, compared to the control group. CONCLUSIONS: Positive effects of the support program were observed on two subscales of the SF-36 in the subgroup that did not use ovulation-enhancing agents.
RCT Entities:
AIM: The purpose of this study was to determine the effects of a support program for the stress management of women undergoing fertility treatment to reduce stress related to infertility and treatment. METHODS: We randomly assigned seven institutions into an experimental group (four institutions, n = 96) and a control group (three institutions, n = 44) using cluster randomization. The women in the experimental group were asked to continue stress management homework for 3 months. A nurse provided feedback on the homework every month. Those in the control group were given only the booklet. The primary outcomes were the risk ratios of "depression" and "anxiety" according to the Hospital Anxiety and Depression Scale. The secondary outcomes were "health status" from the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) v2 and "satisfaction" from the Visual Analogue Scale. We excluded 15 women who became pregnant and performed an intention-to-treat analysis of 125 women. RESULTS: There were no differences in the incidence of depression and anxiety between the experimental and control groups. There were significant interaction effects between the program and time in the scores of the two subscales of SF-36 and the summary. There was no difference in satisfaction. The use of ovulation-enhancing agents showed that the scores of "role functioning physical" and "physical component summary" in the non-use subgroup were higher at 2 and 3 months in the experimental group, compared to the control group. CONCLUSIONS: Positive effects of the support program were observed on two subscales of the SF-36 in the subgroup that did not use ovulation-enhancing agents.