Effectiveness of Sacral Massage on Labor Pain, Depression, Stress, and Anxiety (ESMLPDAS)

March 28, 2026 updated by: Ali Malik Tiryag, University of Basrah

Effectiveness of Sacral Massage on Labor Pain, Depression, Stress, and Anxiety: A Randomized Clinical Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Labor is regarded as one of the physiological behaviors in humans that has existed since the beginning of humanity, the formation cycle of which has remained unchanged. Labor is a health state that most women aspire to, at some point in their lives. The first thought that comes to the mind of an expecting woman regarding her delivery is the pain of labor. The pain of labor is the central and universal part of a woman's experience of childbirth. Labor is a normal physiological process, which while it should be an occasion for rejoicing, it also accompanies with it, lots of pain, agony, and discomfort and certain risks. Thus although being a joyful and empowering experience, it can end with negative and tragic results, leaving the woman filled with fear and anxiety for future birth (Labrecque, Nouwen, Bergeron, & Rancourt, 1999). The causes of labor pain can be either physical or psychological. Physical factors include uterine contractions, cervical dilatations, cervical effacements and so on. Psychological factors include fear and anxiety, previous experiences, inadequate support, inadequate knowledge. Pain perceived during labor may be different for each woman (Sethi & Barnabas, 2017). The fear and anxiety that pregnant women experience during the labor process leads to the stretching of pelvic muscles and creates resistance against the repulsive force of the uterus and the repulsive force exerted by women during labor. The extension of the anxiety-related tension in the pelvic muscles causes general fatigue in pregnant women, increased pain and decreased power to cope with the pain. Anxiety also reduces the selfconfidence of an individual. As a result of this situation, pregnant women perceive themselves as incompetent and unskilled. The anxiety experienced during labor directs women to caesarean section by their own will (Fenwick, Staff, Gamble, Creedy, & Bayes, 2010). The essence of midwifery can be with woman providing comfort in labor. Touch communicates caring and reassurance. Manual healing methods used today during delivery include touch and massage therapy. Painful uterine contractions can be treated by applications of pressure with the hands to a woman's back, hips, thighs and sacrum. By massage therapy, pharmacological management during the first stage of labor can be reduced, so fewer negative effects will be there on the fetus and mother (Smith, Levett, Collins, & Jones, 2012). Non-pharmacological and supportive methods that are used to decrease pain are a part of midwifery/nursing practices. Massage is the oldest tactile stimulation method that is used to relieve labor pain. Massage is a manual process performed on the soft tissues of the body for systemic purposes to improve health and well-being. Massage decreases the severity of pain, loosens the spasms and provides general relief during labor (Field, 2010).

Study Type

Interventional

Enrollment (Estimated)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 15-45-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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage
this group will be recieved the sacral massage to identify itd effect on labor pain, depression, anxiety, and stress
Other: Sacral Massage
The participants in the intervention group will be recieved the sacral massage to identify its effect on the labor pain, depression, anxiety, and stress
Other Names:
  • Massage
No Intervention: Control
This group will be recieved the standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor pain
Time Frame: 30 minutes
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
Time Frame: one hour
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
Time Frame: one hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basrah

Investigators

  • Principal Investigator: Sunduss B Baqer, PhD, College of Nursing/University of Basrah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMPDAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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