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NCT Number: NCT07501598

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

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

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Key information

Conditions

Labor Pain Anxiety Disorders Behavior Behavioral Symptoms Depression Labor Anxiety Labor Depression Labor Stress Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Massage

Other

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ali M Mr. Ali Malik Tiryag, MSc

CONTACT

[email protected]

+9647811735332

Sponsors and collaborators

Lead sponsor

University of Basrah

Other

Registry information

Official study title

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

Acronym: ESMLPDAS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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