Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306806244897 Date of Approval: 20/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acute Sleep Hygiene Education Session and Lavender Essential Oil Inhalation Improved Sleep Latency, Well-Being Index, and Fatigue During a Week of Late-Evening Training Sessions in Trained Athletes
Official scientific title Acute Sleep Hygiene Education Session and Lavender Essential Oil Inhalation Improved Sleep Latency, Well-Being Index, and Fatigue During a Week of Late-Evening Training Sessions in Trained Athletes
Brief summary describing the background and objectives of the trial Adequate sleep is essential for athletes' success, complementing their physical and mental training, nutrition, and overall health. However, many athletes struggle with sleep issues, including insufficient quantity and poor quality. Various factors contribute to these sleep disturbances, such as early morning training, increased training load, travel-related issues, and anxiety/stress before important competitions. Night-time training and competition sessions further disrupt athletes' sleep, leading to reduced quantity and quality. These disruptions can hinder performance and recovery. Therefore, it is crucial to identify strategies that can effectively address these sleep disturbances. One such strategy is sleep hygiene education (SHE), which provides recommendations to improve sleep patterns. Implementing SHE in athletes has shown promising results in enhancing sleep duration and reducing daytime sleepiness. Phytotherapy, specifically aromatherapy using essential oils (EOs), has also gained attention in alternative medicine. Aromatherapy has been found to be effective in reducing stress, improving mood, and enhancing sleep quality in healthy adults. Essential oils, particularly lavender essential oil (LEO), have demonstrated positive effects on sleep quality and mood. However, the effects of SHE and LEO inhalation on sleep quality and mood in athletes following late-evening resistance training sessions have not been thoroughly investigated. Therefore, this study aims to explore the impact of combining a sleep hygiene education session and LEO inhalation during a 7-day period of late-evening resistance training sessions on sleep quality and mood states in trained athletes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Sleep disterbance in athletes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 07/03/2023
Actual trial start date 07/03/2023
Anticipated date of last follow up 15/03/2023
Actual Last follow-up date 15/03/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 37
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group 7 days No intervention 11 Uncontrolled
Experimental Group Sleep Hygiene Education Group 7 days The SHE-G informed to follow all sleep hygiene recommendations for the 7-day period. These recommendations include: 1) taking a post-training shower; 2) ensuring a quiet, cool, and dark bedroom environment; 3) removing the bedroom clock; 4) avoiding light-emitting technology devices at least 1 hour before sleep; 5) refraining from consuming caffeine, alcohol, or other stimulants before sleep; 6) drinking at least one glass of high-electrolyte fluids, such as milk, rather than only water between match cessation and bedtime; and 7) eating a light, high glycaemic index meal with few proteins. After the educational session, participants were given a leaflet summarizing the sleep hygiene recommendations to follow between training cessation and bedtime. All participants slept in their usual beds at home. 8
Experimental Group Lavender Essential Oil Group Participants were instructed to use Lavender (Lavandula angustifolia, of the family Lamiaceae) essential oil (LEO) by dripping two drops (equal to 0.14 mL) of the oil onto a cotton ball and placing it at a distance of 5 cm from their nose. They were then asked to inhale the aroma for 10 minutes through normal breathing at their own convenience. 7 days The LEO-G inhaled the LEO every night before sleeping for the 7-day period 9
Experimental Group Combination of Sleep Hyigien Eduction and Lavender essential Oil Inhalation Group Participants were instructed to use Lavender (Lavandula angustifolia, of the family Lamiaceae) essential oil (LEO) by dripping two drops (equal to 0.14 mL) of the oil onto a cotton ball and placing it at a distance of 5 cm from their nose. They were then asked to inhale the aroma for 10 minutes through normal breathing at their own convenience. 7 days CSL-G were asked to inhale the LEO and to follow to the sleep hygiene education recommendation every night before sleeping for the 7-day period 9
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age ≥ 18 years practice resistance training for ≥ 1 h four times a week being morning (M-type) or evening (E-type) chronotype tobacco use history of lower extremity injury or surgery in the 6 months prior to recruitment prior exposure to sleep hygiene education which might have interfered with the validity of the study protocol. Adult: 19 Year-44 Year 20 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2023 Committee for the Protection of Southern Persons
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome In bedtime (IB), out bedtime (OB), sleep latency (SL), sleep efficiency (SE), total time in bed (TTB), total sleep time (TST), wake after sleep onset (WASO), number of Awakenings (N° AW), and average awakening (AW) Every night during the intervention period
Secondary Outcome Well-being indices with Hooper Questionnaire Pre- and Post-intervention period
Secondary Outcome Mood states with the BRUMS questionnaire Pre- and Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High Institute of Sport and Physical Education of Sfax 3.5km Rue Airport Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Atef Salem Sened Gafsa 2190 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Sport and Physical Education of Sfax 3.5km Rue Airport Sfax 3029 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Hamdi Chtourou Road Airport Sfax 3000 Tunisia
Khaled Trabelsi Road Airport Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Salem Atef.salem95@yahoo.com +21623874933 SENED
City Postal code Country Position/Affiliation
Gafsa 2190 Tunisia High Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Hamdi Chtourou h_chtourou@yahoo.fr +21622872095 Road Airport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia High Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Public Enquiries Khaled Trabelsi trabelsikhaled@gmail.com +21654085066 Road Airport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia High Institute of Sport and Physical Education of Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participants data collected during the trial, after de-indentification Informed Consent Form The end f experimentation For every participant, a key
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information