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

July 10, 2023 updated by: Camilo Jose Cela University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Baseline (before starting the intervention) and post-intervention (3 weeks)
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.
Time Frame: Baseline (before starting the intervention) and post-intervention (3 weeks)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Date of birth data. Questionnaire developed by researchers.
Time Frame: Baseline (before starting the intervention)
Date of birth
Baseline (before starting the intervention)
Toxic habits. Questionnaire developed by researchers.
Time Frame: Baseline (before starting the intervention)
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.
Time Frame: Baseline (before starting the intervention)
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.
Time Frame: Post-intervention (3 weeks).
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.
Time Frame: Baseline (before starting the intervention)
Age in years
Baseline (before starting the intervention)
Gender data. Questionnaire developed by researchers.
Time Frame: Baseline (before starting the intervention)
Gender
Baseline (before starting the intervention)
Sleep data. Questionnaire developed by researchers.
Time Frame: Baseline (before starting the intervention)
sleep coexistence during the study (alone or accompanied)
Baseline (before starting the intervention)
Anthropometric data. Questionnaire developed by researchers.
Time Frame: Baseline (before starting the intervention)
Body Mass Index (BMI): height and weight
Baseline (before starting the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Camilo Jose Cela University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Pérez Manchón, Dr, Camilo Jose Cela University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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