NCT06779786

Brief Summary

Tension-type headache (TTH) is a common symptom in intensive care nurses. The nurses' quality of life, ve social ve business life are negatively affected by the ache. This study was conducted in two stages as randomized controlled study design ve a qualitative study, with the purpose of determining the impacts of medicinal lavender or citriodora oil, applied by massage for four weeks, on headache severity ve the life quality of critical care nurses with TTH. Nurses working in the intensive care units of the University of Health Sciences Kayseri City Hospital ve meeting the inclusion criteria were involved in the research. 60 individuals participated in total in the study with simple randomization as, 20 individual's İntervention- 1, 20 individual's İntervention- 2, ve 20 individual's placebo control. Ethics committee approval, informed consent form ve institutional permission were granted for the study. Through four weeks, nurses in Intervention-1 ve Intervention- 2 groups; 3% medicinal lavender/ eucalyptus citriodora oil, in accordance with the oil application protocol, in the first week, every day in the morning ve evening, ve in the second, third ve fourth weeks only in the morning; in the placebo control group, through four weeks; In the first week, every day in the morning ve evening, ve in the second, third ve fourth weeks, only in the mornings, massage with sesame oil was applied. The data of the research, Patient Introduction Form, Visual Analogue Scale (VAS), Short Form SF 36 Quality of Life Scale (KF-36), Application Tracing Chart Researcher ve Nurse Form, were gathered by using oil application protocol. In the evaluation of quantitative data, one-way analysis of variance, multiple comparison test, chi-square test, pearson correlation analysis ve p\<0.05 were accepted for significance. Descriptive ve content analysis methods were used in the evaluation of qualitative data. It was shown that the medical lavender / eucalyptus citriodora oil massage applied on the nurses in the İntervention groups, reduced the TTH significantly ve provided less use of painkillers ve affected the quality-of-life sub-dimensions more positively when compared to the nurses in the placebo control group. The qualitative findings of the study support the quantitative findings. According to these results, in nurses who are working in intensive care units; the use of 3% medicinal lavender oil or 3% eucalyptus citriodora oil can be recommended in the treatment of the TTH symptom

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 1, 2025

Last Update Submit

January 13, 2025

Conditions

Keywords

Eucalyptus, Intensive Care, Nursing; Lavandula; Sesame; Headache

Outcome Measures

Primary Outcomes (1)

  • vas pain assessment-Visual Analog Scale (VAS)

    The VAS scale, was utilised to assess the pain levels of ICU nurses prior to and following the implementation of the intervention. The scale utilised a numerical scale ranging from '0', representing no pain, to '10', representing the most severe pain. The nurses experiencing pain were instructed to indicate on the VAS scale the point that most accurately reflected their pain at that moment, as recorded on the subsequent follow-up chart. the level of tension-type headache.In the present study, it was hypothesised that the mean score on the VAS pain scale would be lower in the aromatherapy intervention groups.

    one month

Secondary Outcomes (1)

  • The Short Form 36 (SF-36) Quality of Life Scale

    one month

Study Arms (3)

Other:Eucalyptus sttriodora oil Group (Aromatherapy Groups):

OTHER

Description: Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of eucalyptus sttriodora (Group 1) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes. Massage application together and again by dropping 2 ml of 3% eucalyptus sttriodora (Intervention 1) oil into the palm. These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.

Other: Group 1 (Aromatherapy Groups):

medicanal lavandula Oil group(Aromatherapy Groups):

OTHER

Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of medicanal lavandula (Group 2) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes. Massage application together and again by dropping 2 ml of 3% medicanal lavandula (Intervention 1) oil into the palm. These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.

Other: Group 2 (Aromatherapy Groups):

Other: Sesame oil group ( plesebo controloil Group)

OTHER

Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of sesame oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the earlobe from top to bottom with the thumb and index finger for four minutes, and again apply 2 ml of sesame oil into the palm. The group was given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands together with the drops.

Other: Group 3 (Placebo Control Group)

Interventions

Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of eucalyptus sttriodora (Group 1) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes. Massage application together and again by dropping 2 ml of 3% eucalyptus sttriodora (Intervention 1) oil into the palm. These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.

Other:Eucalyptus sttriodora oil Group (Aromatherapy Groups):

Group 2(Aromatherapy Groups): Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of medicanal lavandula (Group 2) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes. Massage application together and again by dropping 2 ml of 3% medicanal lavandula (Intervention 1) oil into the palm. These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.

medicanal lavandula Oil group(Aromatherapy Groups):

Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of sesame oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the earlobe from top to bottom with the thumb and index finger for four minutes, and again apply 2 ml of sesame oil into the palm. The group was given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands together with the drops.

Other: Sesame oil group ( plesebo controloil Group)

Eligibility Criteria

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

You may qualify if:

  • Working in a tertiary ICU, able to communicate easily,
  • Not pregnant,
  • Scoring 3 or more on the VAS scale in two measurements,
  • Meeting the TTH criteria defined by the International Headache Society,
  • Headache Classification Committee, diagnosed with TTH by neurology,
  • Experiencing pain as much as possible.
  • Does not use analgesic drugs, complies with the analgesic usage schedule for a month,
  • Does not have a diagnosed chronic disease that may affect the quality of life,
  • Does not vary in the frequency of working shifts,
  • Undertakes not to change the perfume used for a month.
  • İndividuals who were not included in the preliminary application were included in the study.

You may not qualify if:

  • Those who are allergic to the smell of medical lavender oil and eucalyptus sttriodora oil, those who cannot smell,
  • Those who have a history of asthma, those who are diagnosed with migraine and use regular medication for headaches,
  • Those who use other integrative health practices during the treatment process are not included in the application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bartin University

Bartın, 74000, Turkey (Türkiye)

Location

Erciyes University

Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tension-Type HeadacheSeSAME syndromeHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 17, 2025

Study Start

September 1, 2020

Primary Completion

October 1, 2021

Study Completion

July 22, 2022

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
2025- 2026

Locations