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Completed

NCT Number: NCT05273086

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

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.

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Key information

Conditions

Sleep Healthy Lifestyle

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cayetana Ruiz Zaldibar

Madrid, 28692, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Date of birth data. Questionnaire developed by researchers.

    Time frame: Baseline (before starting the intervention)

    Date of birth

  2. 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.

  3. 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.

  4. 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.

  5. Age in years data. Questionnaire developed by researchers.

    Time frame: Baseline (before starting the intervention)

    Age in years

  6. Gender data. Questionnaire developed by researchers.

    Time frame: Baseline (before starting the intervention)

    Gender

  7. Sleep data. Questionnaire developed by researchers.

    Time frame: Baseline (before starting the intervention)

    sleep coexistence during the study (alone or accompanied)

  8. Anthropometric data. Questionnaire developed by researchers.

    Time frame: Baseline (before starting the intervention)

    Body Mass Index (BMI): height and weight

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2022
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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