Negative effects.
headaches, anxiety, depression, decreases in sleep disturbance, sleep-related impairment
SECONDARY
One participant randomized to ST “slightly agreed” that the intervention resulted in lasting negative effects. This individual reported waking up in the middle of night and having trouble getting back to sleep. Qualitative feedback suggested they would have preferred music-based rather than narration-based tools. Similarly, one participant randomized to NW “strongly agreed” that the intervention resulted in lasting negative effects. This individual reported experiencing headaches and worsened sleep following intervention use. Qualitative feedback suggested that the repetitive nature of the sounds featured in the NW tools resulted in increased anxiety. A further nine participants selected “not sure” when asked whether the interventions resulted in negative effects. However, analysis of secondary outcomes showed increases in sleep duration, and decreases in sleep disturbance, sleep-related impairment, and symptoms of depression and anxiety in this subgroup, suggesting they may have misunderstood the question.When investigating reliable deterioration in outcome measures from Participants who reported reliable deterioration from 