The Effect of a Sleep Intervention on Sleep Quality in Nursing Students

NCT05273086 | Completed

• 1 other identifier: Sleep-UCJC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Healthy Lifestyle

Outcome Measures

Primary Outcomes (2)

• 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.

  Kronowise 3.0 wearable wristband individual device. Participants wear the bracelet for 24 hours, 7 days in a row, including weekdays and weekends. Kronowise 3.0 is a multichannel device that continuously records the rhythms of Body Temperature of the skin, Activity (intensity, duration and time), Body Position and light exposure (intensity, type of light, duration and time). All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor. This device is validated as an objective measure of sleep quality equivalent to polysomnography.

  Baseline (before starting the intervention) and post-intervention (3 weeks)

• 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.

  The Pittsburgh Sleep Quality Index (PSQI) is a self-assessed questionnaire that measures sleep quality and disturbances over a 1-month time interval. It consists of 19 self-assessed items that are combined into 7 components for a total score of 0 to 21 points (0 indicates good sleep quality and up to 21 points indicates poor quality). The questionnaire has an internal consistency coefficient of 0.81 in the Spanish population.

  Baseline (before starting the intervention) and post-intervention (3 weeks)

Secondary Outcomes (8)

• Date of birth data. Questionnaire developed by researchers.

  Baseline (before starting the intervention)

• Toxic habits. Questionnaire developed by researchers.

  Baseline (before starting the intervention)

• Physical exercise. The International physical activity questionnaire (IPAQ) is a validated tool to measure the exercise practice of individuals per week.

  Baseline (before starting the intervention)

• Satisfaction with the intervention. Questionnaire developed by researchers.

  Post-intervention (3 weeks).

• Age in years data. Questionnaire developed by researchers.

  Baseline (before starting the intervention)

Study Arms (2)

Sleep intervention program

EXPERIMENTAL

The Sleep Intervention program Group will be subdivided into two groups of 10 participants to receive the sleep quality improvement program. The program consists of 2 sessions of 90 minutes during one week.

Behavioral: Sleep Intervention Group

Control Group

NO INTERVENTION

The control group will continue with their usual routine.

Interventions

Sleep Intervention Group BEHAVIORAL

The intervention group will acquire skills to improve their quality of sleep such as: * Acquisition of notions of chronobiology. * Location of the nervous structures involved in biological rhythms. * Awareness of the existence of three times that direct our biological rhythms, and of the need for them to be synchronized. * Self-knowledge of the chronotype and the degree of adjustment of the three times. * Knowledge of the variables that determine a good quality of sleep. * Applications of chronobiology to the field of nursing. Recommendations for nurses and patients. * Self-knowledge of the quality of sleep and the health status of the circadian system.

Sleep intervention program

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

Cayetana Ruiz Zaldibar

Madrid, 28692, Spain

Location

Related Publications (6)

• 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.

  PMID: 15750899 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 16450848 BACKGROUND

• 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.

  PMID: 22734575 BACKGROUND

• 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.

  PMID: 25515274 BACKGROUND

• 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.

  PMID: 31031690 BACKGROUND

Study Officials

• David Pérez Manchón, Dr

  Camilo Jose Cela University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 10, 2022
• Study Start: September 19, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)