CClinicalTrials.gg
CompletedNCT04382833Updated May 11, 2020

MASSAGE AND HOT APPLICATION ON LABOR

An interventional study of HOT APPLICATION and MASSAGE in Labor Pain, sponsored by Balikesir University. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-11.

Sponsored by Balikesir University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Jun 2016, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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).

Read the 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

02

Conditions studied

  • Labor Pain

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Keywords

  • comfort at labor
  • labor pain
  • hot application
  • massage
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Balikesir University is the lead sponsor of 57 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • multioarous pregnant women
  • preterm labor
  • multiple pregnancy
  • complicated pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    HOT APPLICATION GROUP

    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.

    Other: HOT APPLICATION

  • Experimental
    MASSAGE GROUP

    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.

    Other: MASSAGE

  • No intervention
    CONTROL GROUP

Interventions

  • OtherHOT APPLICATION

    HOT APPLICATION

  • OtherMASSAGE
06

What researchers measure

Primary outcomes

  1. severity of labor pain assessed by Numerical Rating Scale

    Labor pain level, Numerical Rating Scale

    Time frame: 4-5 cm, 6-7 cm and 8-9 cm cervical dilation at labor

  2. comfort level at labor

    Comfort level, Childbirth Comfort Questionnaire

    Time frame: 4-5 cm and 8-9 cm cervical dilation at labor

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04382833
Lead sponsor
Balikesir University
Responsible party
Hülya TÜRKMEN (Lecturer (PhD), Balikesir University) — Principal investigator
First posted
May 11, 2020
Start date
Jun 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
May 11, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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