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

NCT ID: NCT05273086

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Sleep Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep Intervention Group

Intervention Type 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.

Control Group

The control group will continue with their usual routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Camilo Jose Cela University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Pérez Manchón, Dr

Role: PRINCIPAL_INVESTIGATOR

Camilo Jose Cela University

Locations

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Cayetana Ruiz Zaldibar

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 15750899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16450848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22734575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25515274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31031690 (View on PubMed)

Other Identifiers

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Sleep-UCJC

Identifier Type: -

Identifier Source: org_study_id

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