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Aromatherapy for Reducing Labor Pain

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ClinicalTrials.gov Identifier: NCT03098212
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Kuntharee Traisrisilp, ChaingMai University

Brief Summary:

Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy group will receive the aromatherapy during labor along with standard pain control.

Non-aromatherapy group will receive standard pain control during labor


Condition or disease Intervention/treatment Phase
Pain Other: Aromatherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Aromatherapy for Reducing Pain During Labor
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Aromatherapy
Receive essential oil diffuse by Aroma diffuser during labor. Pain score and dose of analgesics drug are recorded
Other: Aromatherapy
On the day of admission for labor. Pregnant women select type of essential oil. Aroma diffuser is used during labor. Pain score was record during latent, early active and late active phase.

No Intervention: Non-aromatherapy
This group receive pain control by standard of care without essential oil (aromatherapy)



Primary Outcome Measures :
  1. early active phase pain using Visual Analog Scale [ Time Frame: The day of labor ]
    Visual analog scale used to assess pain during cervical dilate 5-7 cm.


Secondary Outcome Measures :
  1. latent phase pain using Visual Analog Scale [ Time Frame: The day of labor ]
    Visual analog scale used to assess pain during cervical dilate 3-4 cm.

  2. late active phase pain using Visual Analog Scale [ Time Frame: The day of labor ]
    Visual analog scale used to assess pain during cervical dilate 8-10 cm.

  3. analgesic drug [ Time Frame: The day of labor ]
    doses of analgesic drug request by pregnant women



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Nulliparous
  • 37 complete weeks of gestation
  • Cephalic presentation
  • No emergency obstetric complication
  • In labor

Exclusion Criteria:

  • Medical or obstetric complication preclude vaginal delivery
  • Essential oil allergy
  • Side effect of aromatherapy

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Responsible Party: Kuntharee Traisrisilp, Principle investigator, ChaingMai University
ClinicalTrials.gov Identifier: NCT03098212     History of Changes
Other Study ID Numbers: 3487
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No