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Labor PainNCT04382833

MASSAGE AND HOT APPLICATION ON LABOR

A study testing HOT APPLICATION and MASSAGE in people with Labor Pain, run by Balikesir University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain
What is being tested?
HOT APPLICATION and MASSAGE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Jun 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: EFFECTS OF MASSAGE AND HOT APPLICATION ON LABOR PAIN AND COMFORT

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

Conditions
Labor Pain
Being tested
HOT APPLICATION, MASSAGE
Keywords
comfort at labor, labor pain, hot application, massage
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOT APPLICATIONOther

    HOT APPLICATION

  • MASSAGEOther

Study groups in NCT04382833
Study groupRoleWhat they receive
HOT APPLICATION GROUPExperimentalThermoforming, 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.
Receives: Other: HOT APPLICATION
MASSAGE GROUPExperimentalMassage 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.
Receives: Other: MASSAGE
CONTROL GROUPNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. severity of labor pain assessed by Numerical Rating Scale

    Labor pain level, Numerical Rating Scale

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

  2. comfort level at labor

    Comfort level, Childbirth Comfort Questionnaire

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study startJun 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382833
Sponsor's protocol ID
BalıkesirU
Status last verified
May 2020
First submitted
4 May 2020
Last updated
11 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HOT APPLICATION and MASSAGE in people with Labor Pain, run by Balikesir University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

severity of labor pain assessed by Numerical Rating Scale (time frame: 4-5 cm, 6-7 cm and 8-9 cm cervical dilation at labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.

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