Clinical trial NCT05273086: The Effect of a Sleep Intervention on Sleep Quality in Nursing Students
Official title: The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Healthy Lifestyle
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The sleep quality in university students is diminished by numerous factors such as alterations in lifestyles, changes, the socio-emotional development or academic performance.The detriment in the quality of sleep can have a negative effects on the quality of life and mental health. It is even a risk factor for cardiovascular diseases. This study is a pilot type clinical trial in which it is intended to implement an intervention to improve the quality of sleep of university nursing students. A randomization of 40 students will be carried out to two treatment groups (intervention n=20 and control n=20). The intervention group will receive two 90-minute sessions during a week where the anatomical structures involved in sleep will be analyzed, workshops will be held to improve the quality of sleep with individual indications after analyzing their rhythms and patterns. The control group will continue with their usual routine.A pre-post evaluation will be carried out on both groups using the Kronowise 3.0 individual wearable bracelet device that measures sleep quality based on general indicators, sleep, wakefulness, internal time, circadian rhythms, temperature, activity, position and light. In addition, information on perceived sleep quality will be collected with the Pittsburgh questionnaire. Sociodemographic data will be collected in the pre measurement for both groups and satisfaction with the program will be collected in the post measurement in the intervention group.

Detailed description: The program consists of 2 sessions of 90 minutes during one week. In the first session, four activities will be carried out: 1) Explanation of the concepts of chronobiology, biological rhythms of the human being, internal clock and synchronizer, and the importance of anatomical structures; 2) Location of the structures mentioned in diagrams and anatomical models of the nervous system; 3) Approach to the concept of chronotype and the existence of three times that affect human circadian rhythms (biological, artificial and social), and how a poor coupling between them leads to a state called chronodisruption; 4) Completion of 2 self-knowledge questionnaires about the sleep pattern. The second session will also consist of four activities: 1) Recommendations on skills to have optimal sleep quality; 2) Carrying out a questionnaire on daytime sleepiness; 3) Applications of the recommendations to the nursing field (work shifts, clinical application in patients); Delivery of the reports to the participants, resolution of questions related to them, and group analysis of the reports of patients with certain circadian pathologies.

Eligibility criteria: Inclusion Criteria:

* Students between 18 and 25 years old.
* Students enrolled in the first full Nursing course at Camilo Jose Cela University 2022-23

Exclusion Criteria:

* Previous diagnosis of mental pathology and/or sleep disorders without or with medication (hypnotics, sedatives and melatonin).
* Work activity simultaneous to academic training.

Primary outcomes:
measure: Change from baseline sleep quality at after intervention. Number of participants who improve their quality of sleep after the intervention evaluated by Kronowise 3.0.
timeFrame: Baseline (before starting the intervention) and post-intervention (3 weeks)
measure: Change from baseline perceived sleep quality at after intervention. The Pittsburgh Sleep Quality Index (PSQI) is a vañidated tool that measures the perceived sleep quality.
timeFrame: Baseline (before starting the intervention) and post-intervention (3 weeks)
Secondary outcomes:
measure: Date of birth data. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
measure: Toxic habits. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
measure: Physical exercise. The International physical activity questionnaire (IPAQ) is a validated tool to measure the exercise practice of individuals per week.
timeFrame: Baseline (before starting the intervention)
measure: Satisfaction with the intervention. Questionnaire developed by researchers.
timeFrame: Post-intervention (3 weeks).
measure: Age in years data. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
measure: Gender data. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
measure: Sleep data. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
measure: Anthropometric data. Questionnaire developed by researchers.
timeFrame: Baseline (before starting the intervention)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cayetana Ruiz Zaldibar
Study officials:
affiliation: Camilo Jose Cela University
name: David Pérez Manchón, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish.
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: Brown FC, Buboltz WC Jr, Soper B. Development and evaluation of the Sleep Treatment and Education Program for Students (STEPS). J Am Coll Health. 2006 Jan-Feb;54(4):231-7. doi: 10.3200/JACH.54.4.231-237.
citation: Blazquez A, Martinez-Nicolas A, Salazar FJ, Rol MA, Madrid JA. Wrist skin temperature, motor activity, and body position as determinants of the circadian pattern of blood pressure. Chronobiol Int. 2012 Jul;29(6):747-56. doi: 10.3109/07420528.2012.679328.
citation: Azad MC, Fraser K, Rumana N, Abdullah AF, Shahana N, Hanly PJ, Turin TC. Sleep disturbances among medical students: a global perspective. J Clin Sleep Med. 2015 Jan 15;11(1):69-74. doi: 10.5664/jcsm.4370.
citation: Madrid-Navarro CJ, Puertas Cuesta FJ, Escamilla-Sevilla F, Campos M, Ruiz Abellan F, Rol MA, Madrid JA. Validation of a Device for the Ambulatory Monitoring of Sleep Patterns: A Pilot Study on Parkinson's Disease. Front Neurol. 2019 Apr 11;10:356. doi: 10.3389/fneur.2019.00356. eCollection 2019.