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Not yet recruitingNCT06499402Updated Jul 15, 2024

The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction

An interventional study of massage in Labor Pain and Labor, sponsored by Osmaniye Korkut Ata University. Not yet recruiting. Open to female participants aged 18 Days to 45 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Osmaniye Korkut Ata University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Days to 45 Days
Sex
Female
01

Study summary

Our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers' labor pain, perception, process and midwives' satisfaction. The research was planned as a randomized controlled experimental study. A total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. In this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. Pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "Individual Identification Form", "Visual Comparison Scale", "Labor Monitoring Form", "Mother's Birth Perception Scale (ADAS)". The satisfaction of midwives will be evaluated with the "Evaluation of Satisfaction Status of Midwives Form".

02

Conditions studied

  • Labor Pain
  • Labor

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03

In context

Labor Pain

423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.

This study's planned enrollment of 112 is above the median of 100 across 347 interventional studies indexed under Labor Pain.

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Lead sponsor

Osmaniye Korkut Ata University is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Days to 45 Days
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participating in the study voluntarily
  • having a cervical dilatation of 5-6 cm,
  • being between 38-40 weeks of pregnancy,- being a single fetus, having a cephalic presentation,
  • having a fetal weight between 2.5-4 kg,
  • having no vision-hearing problems,
  • having communication and cooperation skills

Exclusion criteria

Exclusion Criteria:

  • having pregnancy complications
  • Those who have acute inflammatory problems in soft tissues, skin or joints, burns, nerve injuries, open wounds, rheumatoid and gouty arthritis,
  • those who have used any non-pharmacological methods will not be admitted.
05

Study design

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

Study arms

  • No intervention
    control group
  • Experimental
    experimental group

    Other: massage

Interventions

  • Othermassage

    sacral massage

06

What researchers measure

Primary outcomes

  1. stress

    questionnaire, stress scale

    Time frame: 1 day

Secondary outcomes

  1. labor pain

    pain scale, VAS

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Aug 2024, 1 month later.

Of 191 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 1 month is below that.

Counting every sponsor, half of 193 studies reached it within 9 months; a quarter within 5 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2024
First posted
Jul 12, 2024
StartEst.
Jul 22, 2024
Primary completionEst.
Aug 22, 2024
CompletionEst.
Sep 22, 2024
Last update
Jul 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06499402
Lead sponsor
Osmaniye Korkut Ata University
Responsible party
Emine Yıldırım (Assistant Professor, Osmaniye Korkut Ata University) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 22, 2024 (estimated)
Primary completion
Aug 22, 2024 (estimated)
Completion
Sep 22, 2024 (estimated)
Last update
Jul 15, 2024

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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