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

The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Pilot Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Healthy Lifestyle
• Intervention / Treatment: Behavioral: Sleep 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cayetana Ruiz Zañdibar, Dr; Phone Number: +34 695829472; Email: crzaldibar@ucjc.edu

Study Locations

• Spain
  • Madrid, Spain, 28692
    • Cayetana Ruiz Zaldibar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep intervention program; 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; 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.
No Intervention: Control Group; The control group will continue with their usual routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Date of birth data. Questionnaire developed by researchers.	Date of birth	Baseline (before starting the intervention)
Toxic habits. Questionnaire developed by researchers.	Data of doses per day regarding the consumption of tobacco, alcohol and drugs.	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.	International physical activity questionnaire (IPAQ) will be used to assess physical activity It is composed of 27-item self-reported physical activity measure collects information about home maintenance activities, gardening, occupational, transportation, free time and sedentary activities. Validity with a Cronbach´s alpha of 0.80. The results are classified into exercise activity levels or categories such as: low, moderate or high. The higher the score, the more level of physical activity they have.	Baseline (before starting the intervention)
Satisfaction with the intervention. Questionnaire developed by researchers.	Participants from the intervention group will be asked about their satisfaction with the program. It will contains information about their opinion regarding its need, and whether they will be able to recommend it to friends or family, using a Likert scale of 0 to 10 developed by researchers, where 0 is nothing and 10 is completely.	Post-intervention (3 weeks).
Age in years data. Questionnaire developed by researchers.	Age in years	Baseline (before starting the intervention)
Gender data. Questionnaire developed by researchers.	Gender	Baseline (before starting the intervention)
Sleep data. Questionnaire developed by researchers.	sleep coexistence during the study (alone or accompanied)	Baseline (before starting the intervention)
Anthropometric data. Questionnaire developed by researchers.	Body Mass Index (BMI): height and weight	Baseline (before starting the intervention)

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Investigators: Principal Investigator: David Pérez Manchón, Dr, Camilo Jose Cela University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Sleep-UCJC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No