NCT07501598

Brief Summary

to identify the effectiveness of sacral massage on labor pain, depression, stress, and anxiety: A randomized clinical trial

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Expected
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 24, 2026

Last Update Submit

March 28, 2026

Conditions

Keywords

LaborPainAnxietyStressDepression

Outcome Measures

Primary Outcomes (3)

  • Labor pain

    This part involves the assessment of pain using the Visual Analog Scale (VAS). (2) The patients were asked to rate the pain before and immediately after the drain tube removal. Hayes and Patterson first used VAS in 1921. (2) The VAS has been demonstrated to be a valid and reliable interval scale. (3) Since the VAS is freely available and open access, its use does not require prior permission. In the 1970s, VAS was first used to assess the quality of life of cancer patients. VAS has been used in numerous studies assessing a range of factors since the 1990s, and more recently, it has been applied to evaluate specific conditions like pain. (4-6) In international literature, VAS has a long history of success and is easy to use. On the 10-centimeter-long scale, which has a left and right end for "no pain" and "severe pain," respectively, the subjects can indicate how much pain they are experiencing. The VAS can be used to convert some non-quantifiable values into numerical values. (7)

    30 minutes

  • VAS for pain

    This part involves the assessment of pain using the Visual Analog Scale (VAS). The patients were asked to rate the pain before and immediately after the drain tube removal. Hayes and Patterson first used VAS in 1921. The VAS has been demonstrated to be a valid and reliable interval scale. Since the VAS is freely available and open access, its use does not require prior permission. In the 1970s, VAS was first used to assess the quality of life of cancer patients. VAS has been used in numerous studies assessing a range of factors since the 1990s, and more recently, it has been applied to evaluate specific conditions like pain. In international literature, VAS has a long history of success and is easy to use. On the 10-centimeter-long scale, which has a left and right end for "no pain" and "severe pain," respectively, the subjects can indicate how much pain they are experiencing. The VAS can be used to convert some non-quantifiable values into numerical values.

    one hour

  • Depression, Anxiety, and Stress will be measured by DASS scale

    Depression, Anxiety, and Stress Scale (DASS-21) will be chosen to assess the level of different categories of psychological stress during drain tube removal among post-bariatric surgery patients. The DASS is a series of three self-report scales used to determine the mental states of depression, anxiety, and stress. Each of the three DASS scales has seven elements, that are categorized into subscales, which are all assessed on depression scale, anxiety scale, and stress scale. DASS Arabic was produced by one study. (36) This includes 21 items in a clear and understandable Arabic language, which includes 7 items for depression, 7 items for stress, and 7 items for anxiety. The DASS questionnaire is in the public domain, so permission is not needed. The DASS questionnaire and scoring key were downloaded from the DASS website and copied without restriction. This is the rating scale as follows: (0 did not apply to me at all), (1 applied to me to some degree, or some of the time), (2 applied

    one hour

Study Arms (2)

Massage

EXPERIMENTAL

this group will be recieved the sacral massage to identify itd effect on labor pain, depression, anxiety, and stress

Other: Sacral Massage

Control

NO INTERVENTION

This group will be recieved the standard care only

Interventions

The participants in the intervention group will be recieved the sacral massage to identify its effect on the labor pain, depression, anxiety, and stress

Also known as: Massage
Massage

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year-old primiparous pregnant women
  • singleton pregnancies between 38-42 weeks
  • pregnant women whose labor began spontaneously
  • pregnant women with a healthy fetus
  • pregnant women without any complications that may cause dystocia during labor
  • pregnant women for whom analgesia and anesthesia were not used during the first phase of labor
  • pregnant women who volunteered to participate in the research and who could establish verbal communication.

You may not qualify if:

  • pregnant women with high-risk pregnancies
  • caesarean section indication
  • pregnant women with a chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Field, T. (2010). Pregnancy and labor massage. Expert Review of Obstetrics & Gynecology, 5(2), 177-181

    RESULT
  • Labrecque, M., Nouwen, A., Bergeron, M. & Rancourt, J. F. (1999). A randomized controlled trial of nonpharmacologic approaches for relief of low back pain during labor. The Journal of Family Practice, 48(4), 259-263

    RESULT
  • Sethi, D. & Barnabas, S. (2017). A pre-experimental study to evaluate the effectiveness of back massage among pregnant women in first stage of labour pains admitted in labour room of a selected hospital, Ludhiana, Punjab, India. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 6(1), 76-83. https://doi. org/10.18203/2320-1770.ijrcog20164636.

    RESULT

MeSH Terms

Conditions

Labor PainPainAnxiety DisordersDepression

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sunduss B Baqer, PhD

    College of Nursing/University of Basrah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali M Mr. Ali Malik Tiryag, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

April 20, 2026

Primary Completion

June 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03