NCT05408650

Brief Summary

Poor sleep is common in the ICU, especially among post-operative CABG and more severely ill patients. Additionally, patients after surgery suffer from changes in physiological parameters related to ICU stressors. Pharmacological interventions for sleep improvement can both disrupt and induce sleep and have many negative side effects on intensive care patients. Therefore, this gives the green light for using complementary therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

May 28, 2022

Last Update Submit

June 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire

    Sleep quality will be assessed by Richards-Campbell Sleep Questionnaire which covers five aspects of sleep: depth, latency, frequency of awakening, percentage of time awake, and sleep quality. A total score is obtained by summing each score out of 100, then dividing the total by five and ranking the total score into three categories as follows: * A score from 0 mm to 33 mm indicates poor sleep * A score of between 33 mm to 66 mm indicates normal sleep * A score of over 66 mm indicates very good sleep

    2 days

  • Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.

    Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.

    2 days

Study Arms (2)

Aromatherapy massage group

EXPERIMENTAL

The massage will be applied to the patient's hands and feet while the patient in semi-fowler's position.

Other: Aromatherapy Massage

control group

NO INTERVENTION

The patients will receive the routine care of the ICU (such as decreased movements of the staff and soft light in the area at night).

Interventions

The PI will dilute pure lavender essential oil (Lavandula angustifolia) with almond oil at a dilution rate of 2.5% and apply it to the hands and feet of the patient. * The massage technique including effleurage, petrissage, friction and lymphatic drainage on hands and feet will be adapted from Salvo, (2015) and Youssef and Hassan, (2017). * The massage will be applied to the patient's hands and feet while the patient in semi-fowler's position.

Aromatherapy massage group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult conscious patients ≥ 18 years of both gender
  • ICU length of stay \> 2 nights
  • Physiologically or hemodynamically stable
  • Free from skin problems and fractures in the area of massage

You may not qualify if:

  • Patients who are on sedative drugs or narcotic analgesics
  • Patients with an allergic history to lavender oil
  • Mechanically ventilated patients
  • History of sleep disorders
  • History of mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator (Demonstrator of critical care and emergency nursing)

Study Record Dates

First Submitted

May 28, 2022

First Posted

June 7, 2022

Study Start

July 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06