PainNCT06179966
The Effect of Dance and Massage Applied by Partners at Birth on Birth Pain, Comfort and Satisfaction
A study testing Dance group and Massage group in people with Pain, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Dance group and Massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2023to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- knowing Turkish
- Being over 18 years old
- Having a second vaginal birth
- Being able to go through the labor process with his/her spouse
- Dilation ≤5cm during vaginal examination during admission to labor
- Pregnancy period is between 36-40 weeks
Show all 9Show fewer
- Agreeing to participate in the research with a voluntary consent form
- Do not use any non-pharmacological method before admission to labor. not to have used
- Not using any analgesic or anesthetic medication during labor.
Who cannot join
- Having any chronic disease (DM, HT, Heart Disease)
- Receiving psychiatric treatment (Pharmacotherapy and/or Psychotherapy)
- Presence of a risky pregnancy that prevents normal birth (oligohydramnios, polyhydramnios, twin pregnancy, placental anomalies, presentation and position anomalies)
- Presence of a wound that disrupts skin integrity
- Having given birth 3 or more times
- Being the first pregnancy
Show all 14Show fewer
- Exceeding term (>40 weeks) or premature birth (<36 weeks)
- Presence of previous uterine surgery (caesarean section indication)
- Not having a partner during labor
- Have the necessary examination findings to be accepted into the specified research.
- not having
- The birth process ends with a cesarean section
- Having an operative birth (vacuum, forceps)
- Wants to leave the research voluntarily.
Trial locations and contacts
1 site in 1 country.
About this study
Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different factors). Labor pain; It differs from other types of pain in that it is part of the natural process, occurs within a limited period of time, and the mother willingly endures this pain due to factors such as reuniting with her baby at the end of the process. Due to the possible negative effects of labor pain on maternal and fetal health, the American Society of Anesthesiologists (ASA) and the American Congress of Obstetricians and Gynecologists (ACOG) accept labor pain as an indication that should be treated. recommends that this pain be taken under control. Nowadays, non-pharmacological methods such as "massage, pilates ball, music therapy, acupuncture, aromatherapy" are widely used to manage pain during birth. Massage, which is among the non-pharmacological methods, is the oldest treatment and sensual stimulation method in the world. Massage is generally the first choice method because it has no side effects and is easy to apply. Studies have shown that massage applied during birth provides physical and psychological relief, reduces pain, anxiety, agitation and depressive mood, and increases maternal satisfaction. Determining birth satisfaction is important as it is an indicator of the health status of the mother and newborn as well as the quality of intrapartum care.Birth dance is a combination of music therapy and freedom of movement methods, which is one of the non-pharmacological methods.
Birth dance begins in the active phase of the first stage of labor in order to reduce the pain perceived by the woman and to provide emotional support, and continues until the end of the first stage. The woman is given the opportunity to move rhythmically with someone she prefers (spouse/partner, mother, midwife, etc.), accompanied by relaxing light music. In addition to the music and body movements included in the dance, it is aimed to increase the effectiveness of the applied method by adding spouse/partner support and upright positions and at the same time to provide emotional support to the woman.
Read the detailed description
Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different factors). Labor pain; It differs from other types of pain in that it is part of the natural process, occurs within a limited period of time, and the mother willingly endures this pain due to factors such as reuniting with her baby at the end of the process. Due to the possible negative effects of labor pain on maternal and fetal health, the American Society of Anesthesiologists (ASA) and the American Congress of Obstetricians and Gynecologists (ACOG) accept labor pain as an indication that should be treated. recommends that this pain be taken under control. Different pharmacological and non-pharmacological methods are used to reduce labor pain. Advantages of non-pharmacological methods; These include reducing the rate of use of drugs and eliminating the risk of side effects, being easy and applicable to all individuals, and not imposing an economic burden on the individual.
Nowadays, non-pharmacological methods such as "massage, pilates ball, music therapy, acupuncture, aromatherapy" are widely used to manage pain during birth. Massage, which is among the non-pharmacological methods, is the oldest treatment and sensual stimulation method in the world. Massage is generally the first choice method because it has no side effects and is easy to apply. Studies have shown that massage applied during birth provides physical and psychological relief, reduces pain, anxiety, agitation and depressive mood, and increases maternal satisfaction. Determining birth satisfaction is important as it is an indicator of the health status of the mother and newborn as well as the quality of intrapartum care.
Birth dance is a combination of music therapy and freedom of movement methods, which is one of the non-pharmacological methods.
Birth dance begins in the active phase of the first stage of labor in order to reduce the pain perceived by the woman and to provide emotional support, and continues until the end of the first stage. The woman is given the opportunity to move rhythmically with someone she prefers (spouse/partner, mother, midwife, etc.), accompanied by relaxing light music. In addition to the music and body movements included in the dance, it is aimed to increase the effectiveness of the applied method by adding spouse/partner support and upright positions and at the same time to provide emotional support to the woman.
- Conditions
- Pain
- Being tested
- Dance group, Massage group
- Keywords
- massage, dance, endorphin massage, postpartum comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance groupOther
The application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals.
Massage groupOther
After admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals.
| Study group | Role | What they receive |
|---|---|---|
| Dance group | Experimental | The application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals. Receives: Other: Dance group |
| Massage group | Experimental | After admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals. Receives: Other: Massage group |
| Control Group | No intervention | Routine midwifery care will be provided, and no applications other than routine midwifery care will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period
Measured: 1 hour
Secondary outcomes (4)
Visual Comparison Scale
Visual Comparison Scale (VAS = Visual Analog Scale = VAS) is a reliable scale used in children over the age of seven and conscious patients to determine the severity of pain. The patient is asked to mark his/her own pain on a 10-centimeter line with no pain on one end and the worst possible pain on the other end. Evaluation is made by giving points between 0-10. Evaluation of GKS; It is defined as no pain: 0 cm, mild pain: 0.5 cm - 3.0 cm, moderate pain: 3.5 cm - 6.5 cm, severe pain: 7.0 cm - 10.0 cm.
Measured: during the birth
Postpartum Comfort Scale
WHO; It is a scale that can be used appropriately and safely in measuring the postpartum comfort of mothers who have given birth by normal birth or cesarean section, in meeting postpartum comfort needs, and in evaluating the outcome as a concrete indicator of the outcome. DSKÖ consists of 34 items. A 5-point Likert-type scale scoring system was used to enable an evaluation for each item that determines the situation to be measured. For each item, expressions and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made. The lowest score to be obtained from the scale is 34 and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items and the result is shown in the 1-5 distribution. Basically, low comfort is expressed as 1 and high comfort is expressed as 5.
Measured: 6 hours after birth
Person-Centered Maternity Care Scale
he Turkish form consists of 21 items and 3 sub-dimensions. Except for items 6, 11 and 13 (5 options and coded as 0, 1, 2, 3, 4), the remaining items have 4 options ("no, never" 0, "yes, a few times" 1, "yes, most of the time" "time" is scored as 2, "yes, always" is scored as 3). The lowest score that can be obtained from the total scale is 0, the highest score is 66, the lowest score that can be obtained from the "Valuable and Respectful Care" sub-dimension (2,3,4,5) is 0. The highest score is 12, the lowest score that can be obtained from the sub-dimension "Communication and Autonomy" (1,6,7,8,9,10,11,14) is 0, the highest score is 26, "Supportive Care" (12,13,15,16). The lowest score that can be obtained from the sub-dimension (17,18,19,20,21) is 0 and the highest score is 28. As the score increases, mother-focused care increases
Measured: 6 hours after birth
Birth Satisfaction Scale
DMS consists of 30 Likert-type questions. The score that can be obtained from the scale varies between 30-150 points. As the score obtained from the scale increases, satisfaction with birth increases. Three main themes were identified in the scale: Quality of care (home assessment, birth environment, adequate support and communication with healthcare personnel); personal characteristics of women (ability to cope with childbirth, sense of control, preparation for birth, communication with the baby); Stress experienced during the birth process (difficulty during the birth process, birth injury, perception of receiving adequate medical care, medical interventions, experience of pain, prolonged labor, and the baby's health).
Measured: 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start3 Mar 2023
- Primary completion1 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- KÜBRA YAVAS, Principal investigator, TEKIRDAG CORLU STATE HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179966
- Sponsor's protocol ID
- KırklareliAS-10
- Status last verified
- Jun 2024
- First submitted
- 12 Dec 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dance and Massage Applied by Partners at Birth on Birth Pain, Comfort and Satisfaction
- ClinicalTrials.gov ID
- NCT06179966
- Acronym / sponsor ID
- KırklareliAS-10
- Conditions
- Pain
- Keywords
- massage, dance, endorphin massage, postpartum comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 22 Dec 2023 (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.
Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different factors). Labor pain; It differs from other types of pain in that it is part of the natural process, occurs within a limited period of time, and the mother willingly endures this pain due to factors such as reuniting with her baby at the end of the process. Due to the possible negative effects of labor pain on maternal and fetal health, the American Society of Anesthesiologists (ASA) and the American Congress of Obstetricians and Gynecologists (ACOG) accept labor pain as an indication that should be treated. recommends that this pain be taken under control. Nowadays, non-pharmacological methods such as "massage, pilates ball, music therapy, acupuncture, aromatherapy" are widely used to manage pain during birth. Massage, which is among the non-pharmacological methods, is the oldest treatment and sensual stimulation method in the world. Massage is generally the first choice method because it has no side effects and is easy to apply. Studies have shown that massage applied during birth provides physical and psychological relief, reduces pain, anxiety, agitation and depressive mood, and increases maternal satisfaction. Determining birth satisfaction is important as it is an indicator of the health status of the mother and newborn as well as the quality of intrapartum care.Birth dance is a combination of music therapy and freedom of movement methods, which is one of the non-pharmacological methods.
Birth dance begins in the active phase of the first stage of labor in order to reduce the pain perceived by the woman and to provide emotional support, and continues until the end of the first stage. The woman is given the opportunity to move rhythmically with someone she prefers (spouse/partner, mother, midwife, etc.), accompanied by relaxing light music. In addition to the music and body movements included in the dance, it is aimed to increase the effectiveness of the applied method by adding spouse/partner support and upright positions and at the same time to provide emotional support to the woman.
Detailed description
Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different factors). Labor pain; It differs from other types of pain in that it is part of the natural process, occurs within a limited period of time, and the mother willingly endures this pain due to factors such as reuniting with her baby at the end of the process. Due to the possible negative effects of labor pain on maternal and fetal health, the American Society of Anesthesiologists (ASA) and the American Congress of Obstetricians and Gynecologists (ACOG) accept labor pain as an indication that should be treated. recommends that this pain be taken under control. Different pharmacological and non-pharmacological methods are used to reduce labor pain. Advantages of non-pharmacological methods; These include reducing the rate of use of drugs and eliminating the risk of side effects, being easy and applicable to all individuals, and not imposing an economic burden on the individual.
Nowadays, non-pharmacological methods such as "massage, pilates ball, music therapy, acupuncture, aromatherapy" are widely used to manage pain during birth. Massage, which is among the non-pharmacological methods, is the oldest treatment and sensual stimulation method in the world. Massage is generally the first choice method because it has no side effects and is easy to apply. Studies have shown that massage applied during birth provides physical and psychological relief, reduces pain, anxiety, agitation and depressive mood, and increases maternal satisfaction. Determining birth satisfaction is important as it is an indicator of the health status of the mother and newborn as well as the quality of intrapartum care.
Birth dance is a combination of music therapy and freedom of movement methods, which is one of the non-pharmacological methods.
Birth dance begins in the active phase of the first stage of labor in order to reduce the pain perceived by the woman and to provide emotional support, and continues until the end of the first stage. The woman is given the opportunity to move rhythmically with someone she prefers (spouse/partner, mother, midwife, etc.), accompanied by relaxing light music. In addition to the music and body movements included in the dance, it is aimed to increase the effectiveness of the applied method by adding spouse/partner support and upright positions and at the same time to provide emotional support to the woman.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dance group | Experimental | Other: Dance groupThe application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals. |
| Massage group | Experimental | Other: Massage groupAfter admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals. |
| Control Group | No intervention | –Routine midwifery care will be provided, and no applications other than routine midwifery care will be performed. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- knowing Turkish
Key exclusion criteria (14 listed)
- Having any chronic disease (DM, HT, Heart Disease)
- not having
- The birth process ends with a cesarean section
- Having an operative birth (vacuum, forceps)
- Wants to leave the research voluntarily.
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 |
|---|---|---|
| Dance groupThe application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals. | Other | Dance group |
| Massage groupAfter admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals. | Other | Massage group |
Primary outcome
Introductory Information Form
Time frame: 1 hour
sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period
4 secondary outcomes
Visual Comparison Scale
Time frame: during the birth
Postpartum Comfort Scale
Time frame: 6 hours after birth
Person-Centered Maternity Care Scale
Time frame: 6 hours after birth
Birth Satisfaction Scale
Time frame: 2 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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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. This study is not recruiting at the moment.
KÜBRA YAVAS principal investigator
TEKIRDAG CORLU STATE HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance group and Massage group in people with Pain, run by Kırklareli University at 1 site in Turkey (Türkiye).
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2024.