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Sleep Promotion for patients undergoing Heart Disease Treatment: randomized clinical trial

Sleep Promotion for patients undergoing Percutaneous Intervention for the treatment of Heart Disease: randomized clinical trial - PROSOCARD PROSOCARD - sleep promotion for patients undergoing percutaneous intervention to treat heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2pcycpx
Enrollment
Unknown
Registered
2020-12-15
Start date
2020-12-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Hygiene

Interventions

ntervention group: 40 patients will use ear protectors and eye masks for night use during their stay in the Intensive Care Unit. Control group: 40 patients will receive the usual care during the night
E07.700.250

Sponsors

Universidade de São Paulo
Lead Sponsor

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years, communication and comprehension skills preserved.

Exclusion criteria

Exclusion criteria: Report of severe sleep disorder requiring daily treatment before hospitalization, such as sleep apnea, narcolepsy and chronic insomnia; presence of serious complication (aortic dissection, bleeding or stroke after the procedure) related to the treatment; presence of delirium as medical record evaluation; severe hearing and visual loss; history of neurological disease or diagnosed psychiatric disorders; admission to the Intensive Care Unit between 9:00 pm to 6:00 am after the percutaneous intervention procedure; treatment with mechanical ventilation; need for sedation during stay in the ICU, who are not fluent in the Portuguese language.

Design outcomes

Primary

MeasureTime frame
To evaluate the quality of sleep of the participants in the control and intervention groups measured by the instruments after applying the intervention daily during their stay in the ICU. Participants in the intervention group are expected to have higher sleep quality scores

Secondary

MeasureTime frame
The daytime sleepiness of the participants in the intervention group is expected to have lower scores according to the specific assessment instrument;The incidence of delirium is expected to be lower in the intervention group measured by the specific instrument.

Countries

Brazil

Contacts

Public ContactRegina Claudia Souza
rcssouza@usp.br+551130913116

Outcome results

None listed

Source: REBEC (via WHO ICTRP)