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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Basrah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings