Effects of an online program about intimate and romantic relationships for people with mental disorders (AIRIKI): a study protocol for a randomized controlled trial.

BACKGROUND: The concept of recovery has become internationally widespread. To promote personal recovery of individuals with mental disorders, it is important that they live life on their own terms. Many people with mental disorders wish to build intimate relationships and marry. However, people with mental disorders face obstacles in building such relationships and communicating with their partners. The program AIRIKI, which means "power to love," was developed to help people with mental disorders gain confidence in building intimate relationships. The AIRIKI pilot study with one-group pre post test showed positive effects on self-esteem, hope, and communication. Therefore, the purpose of the proposed randomized controlled trial (RCT) is to determine the effects of the videoconferencing program on self-esteem, hope, and self-confidence in communication among un-married people with mental disorders. METHODS: The proposed randomized controlled trial has two arms (intervention group and control group). After baseline questionnaire assessment, participants will be allocated randomly. Within two months of allocation, the intervention group will participate in videoconferences about intimate relationships and marriage with 2-5 participants and 3 facilitators, which will last 3 h, for two days. Three facilitators will support participants in each session. The intervention group will complete a questionnaire for outcome assessment at termination and one month after the program. The control group will complete the outcome questionnaire at one month after baseline and two months after baseline. The questionnaire will include the Rosenberg Self-Esteem Scale (RSES), Herth Hope Index (HHI), and Self-confidence in Communication Scale (SCS). Control group members can participate in a videoconference program, which will be held separately from the intervention group, after completing their outcome assessments. DISCUSSION: This trial is the first randomized controlled trial of which we are aware to test the effects of an online program for un-married people with mental disorders to consider and discuss their romantic relationship and marriage. The results will provide information on the effectiveness of an online program for people with mental disorders to imagine their romantic relationships and marriages. TRIAL REGISTRATION: This trial has been registered with the UNIN Clinical Trials Registry (UMIN000052027; 2023/08/28).

The Effects of a Yoga Exercise and Nutritional Guidance Program on Pregnancy Outcomes Among Healthy Pregnant Japanese Women: A Study Protocol for a Randomized Controlled Trial.

OBJECTIVES: This report provides an experimental protocol for a study designed to verify the effects of yoga exercise and a nutritional guidance program during pregnancy on several key pregnancy and birth outcomes among Japanese women. DESIGN: This is a study protocol of a randomized controlled trial. SETTING/LOCATION: This intervention will be carried out in a university hospital in Tokyo. SUBJECTS: Healthy primiparous women will be recruited at 18-23 gestational weeks in the hospital. A total of 400 participants will be randomly assigned to one of four groups in this trial, with 100 participants in each group-group with yoga exercise, with nutritional guidance, with both yoga and nutritional guidance, and with standard care alone, as the control group. Yoga exercise consists of yoga classes held at the hospital 3 or 5 days a month, duration 60 min, and home practice using a digital video disk, duration 30 or 60 min per session. We recommend participants do yoga at least 3 days a week for a total of 60 min per day. Nutritional guidance is based on individual dietary intake assessed using a brief-type diet history questionnaire. RESULTS: The primary outcome is rate of pregnant women with adequate gestational weight gain. Secondary outcomes include physiologic and psychologic status assessed via biomarkers and health-related scales, dietary nutrition intake, and birth outcomes. CONCLUSIONS: This study shows the effects of a yoga exercise and nutritional intervention. If the intervention is found to be effective, our results will be useful for healthcare providers and pregnant women.

Immediate stress reduction effects of yoga during pregnancy: One group pre-post test.

BACKGROUND: Excessive stress during pregnancy may cause mental disorders in pregnant women and inhibit fetal growth. Yoga may alleviate stress during pregnancy. AIM: To verify the immediate effects of yoga on stress response during pregnancy. METHODS: One group pre-post test was conducted at a hospital in Japan. We recruited 60 healthy primiparas without complications and asked them to attend yoga classes twice a month and to practice yoga at their homes using DVD 3 times a week from 20 gestational weeks until childbirth. Salivary cortisol and alpha-amylase concentration were measured before and after yoga classes at time 1 (27-32 gestational weeks) and time 2 (34-37 gestational weeks). Subjective mood was assessed using the profile of mood states. Saliva values and mood scores before and after each yoga class were compared using paired t-test and Wilcoxon rank-sum test, respectively. FINDINGS: We analyzed 44 and 35 women at time 1 and time 2, respectively. The mean salivary cortisol concentration declined significantly after each yoga class [time 1: 0.36-0.26µg/dL (p<0.001), time 2: 0.32-0.26µg/dL (p=0.001)]. The mean salivary alpha-amylase concentration also decreased significantly following each class [time 1: 72.2-50.8kU/L (p=0.001), time 2: 70.6-52.7kU/L (p=0.006)]. The scores for negative dimensions of mood (Trait-Anxiety, Depression, Anger-Hostility, Fatigue, and Confusion) decreased significantly. The scores of Vigor for a positive dimension of mood significantly increased. CONCLUSION: This study indicated the immediate stress reduction effects of yoga during pregnancy.

Daily walking decreases casual glucose level among pregnant women in the second trimester.

The objective of this study was to explore the relationship between carbohydrate metabolism and the number of steps walked daily, as evaluated by accelerometer, among Japanese women in the second trimester of pregnancy. This longitudinal study was conducted at a university hospital in Tokyo, Japan, from August 2012 to January 2013. Healthy pregnant women at 14 to 18 gestational weeks were recruited. Participants wore accelerometers on the waist for 4 weeks. Casual glucose and hemoglobin A1c (HbA1c) levels were compared between two groups based on whether participants habitually walked ≥ 6,000 steps/day or < 6,000 steps/day. Fifty-one pregnant women were included in the present study; data from 35 were analyzed. There were 22 women in the group that habitually walked ≥ 6,000 steps/day and 13 in the group habitually walking < 6,000 steps/day. Although the median serum casual glucose level at the end of the investigation was 90.0 mg/dL in the group walking < 6,000 steps/day, the level in the group walking ≥ 6000 steps/day was 83.5 mg/dL (p = 0.01). HbA1c levels were not significantly different between the two groups. Our results suggest that walking as a daily habitual physical activity is effective for controlling casual glucose levels in the second trimester of pregnancy.