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MASSAGE AND HOT APPLICATION ON LABOR

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HOT APPLICATION
MASSAGE
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring comfort at labor, labor pain, hot application, massage

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • primiparous pregnant women
  • vaginal delivery expectancy
  • term pregnancy
  • single healthy fetus
  • active labor stage (4-5 cm cervikal dilation)

Exclusion Criteria:

  • multioarous pregnant women
  • preterm labor
  • multiple pregnancy
  • complicated pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    HOT APPLICATION GROUP

    MASSAGE GROUP

    CONTROL GROUP

    Arm Description

    Thermoforming, one of the dry hot application methods, was performed on the sacral (S1-S4) vertebrae region of pregnant women in the hot application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). Thermoforming was applied by wrapping it with a towel to protect pregnant women from the direct effect of its hot surface. The mean water temperature used in thermoforming was 50C. The water temperature was measured using a liquid thermometer. When 50°C water was subjected to hot application, the surface temperature reached around 40°C. The hot application was carried out continuously for 20 min.20 The body temperature of the pregnant women was evaluated before the application.

    Massage using effleurage and friction techniques was applied to the 4-5 cm right and left lateral parts of the midline on the sacral (S1-S4) vertebrae region of pregnant women in the massage application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). The massage application was carried out continuously for only 10 min because it was thought to cause irritation to the area where it was practiced.

    Outcomes

    Primary Outcome Measures

    severity of labor pain assessed by Numerical Rating Scale
    Labor pain level, Numerical Rating Scale
    comfort level at labor
    Comfort level, Childbirth Comfort Questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2020
    Last Updated
    May 6, 2020
    Sponsor
    Balikesir University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04382833
    Brief Title
    MASSAGE AND HOT APPLICATION ON LABOR
    Official Title
    EFFECTS OF MASSAGE AND HOT APPLICATION ON LABOR PAIN AND COMFORT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Balikesir University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Aim: This study aimed to examine the effects of sacral massage and hot application on labor pain and comfort level perceptions in pregnant women. Methods: This randomized controlled experimental study included hot application, massage and control groups, each having 30 primiparous pregnant women whose cervix was dilated to 4-5 cm. The intervention groups were given a sacral massage or sacral hot application, whereas the control group was given only standard midwifery care during 4-5, 6-7, and 8-9 cm cervical dilation. The data were collected using the Introductory Information Form, the Childbirth Comfort Questionnaire (CCQ), and the Numerical Rating Scale (NRS).
    Detailed Description
    This randomized controlled experimental study was carried out between June and December 2016 in the delivery room of Public Hospital in Turkey.The sample size was determined using power calculations G*Power 3 with taking into account previous studies in which a effects massage and hot application on labor pain. Estimates of effects were derived from the findings of previous studies. The sample size was calculated at the 5% level of significance and a power of 95% based on previous studies (n = 30 in each group). The study sample consisted of primiparous pregnant women with vaginal delivery expectancy, term pregnancy, single healthy fetus, and active labor stage (4-5 cm dilation). A total of 98 primiparous pregnant women were included in the study, but 8 of them were excluded because of delivery by cesarean section. Thus, three research groups were formed as follows: massage, hot application, and control groups (n =30 in each group). Sacral massage and sacral hot application were applied to the intervention groups, and only standard midwifery care was given to the control group. Randomization was performed when each pregnant woman who was admitted to the hospital during labor and met the inclusion criteria. Randomization was provided with the collection of data on Mondays, Wednesdays, and Fridays of each week during the study period. Sacral massage was applied on Mondays, sacral hot application was performed on Wednesdays, and data of the control group were collected on Fridays. Cervical dilation and effacement, contraction, fetal heartbeat rate, and vital findings were followed in the standard midwifery care. Midwives informed pregnant women about breathing and evacuation techniques. In addition, all pregnant women in labor process received induction application. Each study group was given a descriptive information form, Childbirth Comfort Questionnaire (CCQ), and Numerical Rating Scale (NRS) in the active stage of labor (4-5 cm cervical dilation). Standard midwifery care was given to each group, and intervention groups were interfered three times in total, during 4-5, 6-7, and 8-9 cm cervical dilation. Immediately after each intervention, NRS was administered between contractions. CCQ was also applied between contractions after the last intervention made during 8-9 cm cervical dilation. Pregnant women in the control group filled NRS during 4-5 and 6-7 cm cervical dilation, and CCQ during 8-9 cm cervical dilation. NRS was applied for the last time in all three groups 5 min after the third stage of labor. Childbirth Comfort Questionnaire-CCQ: This scale was developed by Schuling and Sampselle (2003), and the Turkish validity and reliability study of the scale was carried out by Potur et al (2015). Potur et al. (2015) showed that the sociocultural subscale had item total score correlation coefficient less than 0.30, and the items showing the relief level were extracted from the scale. The CCQ consisted of physical, environmental, and psychospiritual subscales and a specific sense of relief and transcendence. It was a 5-point Likert-type scale with nine items. Each item scored between strongly disagree (1 point) to strongly agree (5 points). It is possible to score from 9 to 45 when all questions on the scale are answered. High score referred to high comfort and vice versa. In the present study, CCQ was applied two times in total, one before the intervention during 4-5 cm cervical dilation and one immediately after the intervention during 8-9 cm cervical dilation. Numerical Rating Scale (NRS): This scale was used to evaluate pain levels.Subjects were asked to rate the level of their pain using the numbers from 0 (no pain) to 10 (worst imaginable pain) on this scale. In the present study, NRS was applied five times in total, one before the intervention, three times immediately after interventions (during 4-5, 6-7, and 8-9 cm cervical dilations) and one after delivery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain
    Keywords
    comfort at labor, labor pain, hot application, massage

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HOT APPLICATION GROUP
    Arm Type
    Experimental
    Arm Description
    Thermoforming, one of the dry hot application methods, was performed on the sacral (S1-S4) vertebrae region of pregnant women in the hot application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). Thermoforming was applied by wrapping it with a towel to protect pregnant women from the direct effect of its hot surface. The mean water temperature used in thermoforming was 50C. The water temperature was measured using a liquid thermometer. When 50°C water was subjected to hot application, the surface temperature reached around 40°C. The hot application was carried out continuously for 20 min.20 The body temperature of the pregnant women was evaluated before the application.
    Arm Title
    MASSAGE GROUP
    Arm Type
    Experimental
    Arm Description
    Massage using effleurage and friction techniques was applied to the 4-5 cm right and left lateral parts of the midline on the sacral (S1-S4) vertebrae region of pregnant women in the massage application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). The massage application was carried out continuously for only 10 min because it was thought to cause irritation to the area where it was practiced.
    Arm Title
    CONTROL GROUP
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    HOT APPLICATION
    Intervention Description
    HOT APPLICATION
    Intervention Type
    Other
    Intervention Name(s)
    MASSAGE
    Primary Outcome Measure Information:
    Title
    severity of labor pain assessed by Numerical Rating Scale
    Description
    Labor pain level, Numerical Rating Scale
    Time Frame
    4-5 cm, 6-7 cm and 8-9 cm cervical dilation at labor
    Title
    comfort level at labor
    Description
    Comfort level, Childbirth Comfort Questionnaire
    Time Frame
    4-5 cm and 8-9 cm cervical dilation at labor

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    pregnant womens
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: primiparous pregnant women vaginal delivery expectancy term pregnancy single healthy fetus active labor stage (4-5 cm cervikal dilation) Exclusion Criteria: multioarous pregnant women preterm labor multiple pregnancy complicated pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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