Labor PainESMLPDASNCT07501598
Effectiveness of Sacral Massage on Labor Pain, Depression, Stress, and Anxiety
A study testing Sacral Massage in people with Labor Pain and Labor Anxiety, run by University of Basrah.
Trial summary
to identify the effectiveness of sacral massage on labor pain, depression, stress, and anxiety: A randomized clinical trial Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor Anxiety, Labor Stress
- What is being tested?
- Sacral Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- pregnant women with high-risk pregnancies
- caesarean section indication
- pregnant women with a chronic illnesses
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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).
- Conditions
- Labor Pain, Labor Anxiety, Labor Stress, Labor Depression
- Being tested
- Sacral Massage
- Keywords
- Labor, Pain, Anxiety, Stress, Depression
- Medical subject headings
- Labor Pain, Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral MassageOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | this group will be recieved the sacral massage to identify itd effect on labor pain, depression, anxiety, and stress Receives: Other: Sacral Massage |
| Control | No intervention | This group will be recieved the standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basrah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Malik Tiryag, University of Basrah
- Investigators
- Sunduss B Baqer, PhD, Principal investigator, College of Nursing/University of Basrah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501598
- Sponsor's protocol ID
- SMPDAS
- Acronym
- ESMLPDAS
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.
PubMed 20479957Labrecque M, Nouwen A, Bergeron M, Rancourt JF. A randomized controlled trial of nonpharmacologic approaches for relief of low back pain during labor. J Fam Pract. 1999 Apr;48(4):259-63.
PubMed 10229249Sethi, 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 at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sacral Massage on Labor Pain, Depression, Stress, and Anxiety: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07501598
- Acronym / sponsor ID
- ESMLPDAS / SMPDAS
- Conditions
- Labor Pain, Labor Anxiety, Labor Stress, Labor Depression
- Keywords
- Labor, Pain, Anxiety, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- University of BasrahUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to identify the effectiveness of sacral massage on labor pain, depression, stress, and anxiety: A randomized clinical trial
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Sacral Massagethis group will be recieved the sacral massage to identify itd effect on labor pain, depression, anxiety, and stress |
| Control | No intervention | –This group will be recieved the standard care only |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant women with high-risk pregnancies
- caesarean section indication
- pregnant women with a chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral MassageAlso: MassageThe participants in the intervention group will be recieved the sacral massage to identify its effect on the labor pain, depression, anxiety, and stress | Other | Massage |
Primary outcome
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)
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 20479957Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.
- Results publication: PubMed 10229249Labrecque M, Nouwen A, Bergeron M, Rancourt JF. A randomized controlled trial of nonpharmacologic approaches for relief of low back pain during labor. J Fam Pract. 1999 Apr;48(4):259-63.
- Results publicationSethi, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunduss B Baqer, PhD principal investigator
College of Nursing/University of Basrah
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Massage in people with Labor Pain and Labor Anxiety, run by University of Basrah.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali M Mr. Ali Malik Tiryag, MSc (+9647811735332, ali.malik@uobasrah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07501598, which also lists 3 linked publications.
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 2 Apr 2026.