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Labor PainNCT03755284

The Effect of Sacral Massage on Labor

A study testing Sacral Massage in people with Labor Pain, run by Semra Çevik, phD at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping with the labour pain, are the methods that allow women to completely relax without using any medication and direct them to perceive the pain at the lowest level. Read more about this study

Who is it for?
Ages 19 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain
What is being tested?
Sacral Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jan 2016to 25 Oct 2016
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 19 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 19-40-year-old primiparous pregnant women;
  • Singleton pregnancies between 38-42 weeks;
  • Pregnant women whose labour began spontaneously;
  • Pregnant women with a healthy foetus;
  • Pregnant women without any complications that may cause dystocia during labour;
  • Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour;
  • Pregnant women who volunteered to participate in the research and who could establish verbal communication.

Who cannot join

  • Pregnant women with high-risk pregnancies, with caesarean section indication, and
  • Pregnant women with a chronic illness were excluded.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gaziantep University

    Gaziantep, Şahinbey, 27000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Sacral Massage On Labour Pain and Anxiety: A Randomized Controlled Trial

Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping with the labour pain, are the methods that allow women to completely relax without using any medication and direct them to perceive the pain at the lowest level. This study was conducted to determine the effect of sacral massage, on labour pain and anxiety. This study was conducted as a randomized controlled experimental study at Bağcılar Training and Research Hospital, Obstetrics and Gynecology Clinic between March and October 2016.

Hypotheses of the Study

  1. Massage applied to the sacral region decreases the perception of a woman's labour pain.
  2. Massage applied to the sacral region decreases the woman's levels of concern and anxiety about labour.
  3. Massage applied to the sacral region increases the woman's satisfaction with the labour
Read the detailed description

Study design

This was a randomized and controlled experimental study aimed to determine the effects of sacral massage on labour pain and anxiety.

Setting and samples

The study was performed in volunteer pregnant women who applied to xxx Training and Research Hospital, Delivery Unit, to undergo their first labour between January 25 and October 25, 2016. This unit contains 1 delivery room (with 2 tables), 2 labour follow-up rooms (with 5 beds), 1 postpartum room (with 5 beds) and 1 nursing room.

According to hospital records, in all, 342 pregnant women who applied to xxx Training and Research Hospital, Delivery Unit to undergo their first labour between January 25 and October 25, 2016, constituted the population of the study. The following inclusion criteria were used to determine participation in the study: (1) 19-40-year-old primiparous pregnant women;(2) Singleton pregnancies between 38-42 weeks; (3) Pregnant women whose labour began spontaneously; (4) Pregnant women with a healthy foetus; (5) Pregnant women without any complications that may cause dystocia during labour; (6) Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour; (7) Pregnant women who volunteered to participate in the research and who could establish verbal communication. In addition, Pregnant women with high-risk pregnancies, with caesarean section indication, and Pregnant women with a chronic illness were excluded.

The sample size was calculated by Medical Faculty Biostatistics Department using Minitab Program. The sample volume to represent the population was determined as minimum 30 people for each group when considering comparison results of mean scores in the study of Field., with a risk of α= 0.05, an accuracy rate of 1-α =0.95 and a power ratio of B= 0.20, 1-B= 0.80.

The study was conducted with two groups, namely Massage Group (experimental), and Control Group. 30 pregnant women were included in each group; therefore, the study was conducted with a total of 60 pregnant women. The women who participated in the study were randomized randomly as control (double) and experimental (single) groups according to the single or double patient admission numbers. The women who participated in the study were randomized into either the control (double) or the experimental (single) group according to single or double patient admission numbers.

Measurements

In this study, the Questionnaire form, Birth action follow-up form, postpartum interview form ,Visual analogue scale (VAS) and State-trait anxiety inventory (STAI FORM TX-I) were used to collect the data.

  1. Questionnaire Form: Questions that reflect the sociodemographic characteristics of the patients (age, educational status, social security, marital status), information about pregnancy (drugs used, status of their willingness to become pregnant, gestational week, status of attending examinations, status of collecting information about labour), the methods used to cope with the pain, and open-ended questions that evaluate the previous use of massage.
  2. Birth Action Follow-Up Form: The questions that indicate the length of the first phase, the interventions performed to shorten the first phase of labour, the methods used by the patient to cope with the labour pain, the emotional behaviours of the pregnant women during labour, the length of the second phase, adjustment of the pregnant women, the presence of intervention in labour, the status of episiotomy, the total duration of labour and the baby's health.
  3. Postpartum Interview Form: Open and closed questions that indicate the pregnant women's thoughts about labour, the status of overall satisfaction with labour and how the women feel were included in this form, which was prepared by a researcher in accordance with the relevant literature.
  4. Visual Analogue Scale (VAS): The Visual Analogue Scale (VAS) was used to measure the severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows: the absence of pain is indicated by "0", while the most severe pain is indicated by "10". In this method, it is explained to the individual that there are two endpoints and that he/she is free to mark any point that defines his/her pain. The VAS was applied to the participants in the control group three times in the latent (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also applied to those in the experimental group two times before and after the massage in each phase. The diagnosis was made in accordance with the subjective data including the patient's verbal expression.
  5. State-Trait Anxiety Inventory (STAI FORM TX-I): To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely. The state-trait anxiety inventory requires the individual to describe how he/she feels at a certain moment and under certain conditions by considering his/her feelings about a specific situation. While high scores indicate high anxiety levels, low scores indicate low anxiety levels. The state-trait anxiety inventory consists of 20 statements. The score obtained from the scale may vary between 20 and 80. While a high score represents a high anxiety level, a low score represents a low anxiety level. In the scoring performed in accordance with the criteria directive, 0-19 points are regarded as "none", 20-39 points are regarded as "mild anxiety", 40-59 points are regarded as "moderate anxiety", 60-79 points are regarded as "heavy anxiety" and 80 points are regarded as "severe anxiety". In our study, the STAI FORM TX-I was used in the active (5-7 cm) phase in the control group and in the active (5-7 cm) phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour.

Data Collection

After approval and permission to conduct the study were obtained from the ethics committee, the hospital's head nurse, delivery room charge nurse/midwife and other midwives and nurses were interviewed and informed about the purpose and scope of the study. Data were collected by one of the researchers. The researcher was aware of which patients were assigned to each group. However, the researchers did not interfere in any way with the study results. When they encountered women who met the inclusion criteria of the study, the purpose of the study was explained, and written consents were received from those who agreed to participate in the study. For the women who satisfied the criteria, participation in the study was voluntary. Additionally, during the study, no women requested to withdraw and no women were excluded from the study. Routine care and treatments for the women continued during data collection.

Procedure

Before the research data were collected, an informative meeting regarding the purpose and scope of the study was held for the members of the healthcare team who worked in the obstetrics and gynaecology clinic of the Turkish Republic Ministry of Health Public Hospitals Administration of Turkey, at the Istanbul Province xxx Training and Research Hospital, where the study would be conducted. In addition, cooperation was provided by the members of the healthcare team. For the correct application of the massage, the researcher was trained by the physical therapist who work at hospital. The massage was applied only to the pregnant women in the intervention group at every phase of labour. There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.

For the pregnant women included in the experimental group:

  • One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed.
  • The prepared questionnaire form was applied.
  • In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.
  • The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the massage in the active (5-7 cm) phase.
  • The Visual Analogue Scale (VAS) was evaluated once after the massage in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases.
  • Birth action follow-up form and postpartum interview forms were applied.

For the pregnant women included in the control group:

  • One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed.
  • The prepared questionnaire form was applied.
  • Routine nursing/midwifery care was applied.
  • The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the active (5-7 cm) phase.
  • The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases.
  • Birth action follow-up form and postpartum interview forms were applied One-on-one interviews were conducted with the women in both groups, and the voluntary disclosure forms, which explained the purpose of the study, were completed. After the prepared questionnaire form was applied to the women in the experimental group, routine nursing/midwifery care was provided.

Data analysis

In the evaluation of the data, in addition to descriptive statistical methods (e.g., percentage, frequency, mean, and standard deviation), the chi-square test and Student's t-test were used in the comparison of the qualitative data. The results were evaluated at a significance level of p <0.05.

The dependent variables of the study are the pain score averages of the pregnant women, the duration of the latent, active and transition phases of labour, and the anxiety level score. The independent variables of the study are the pregnant women's age, educational status, working status, and prenatal educational status, as well as the educational status of the husbands of the pregnant women, their willingness to become pregnant and the willingness to serve as controls before labour.

Conditions
Labor Pain
Being tested
Sacral Massage
Keywords
anxiety, labor pain, massage, surveys and questionnaires, visual analog scale
Medical subject headings
Labor Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral MassageOther

    ● In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.

Study groups in NCT03755284
Study groupRoleWhat they receive
sacral Massage GroupExperimentalThe massage was applied only to the pregnant women in the intervention group at every phase of labour. There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below. For the pregnant women included in the experimental group: In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.
Receives: Other: Sacral Massage
Control GroupNo interventionThere was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below. One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed. The prepared questionnaire form was applied. Routine nursing/midwifery care was applied. The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the active (5-7 cm) phase. The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases. Birth action follow-up form and postpartum interview forms were applied

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The state-trait anxiety inventory (STAI FORM TX-I) evaluated

    The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the massage in the active (5-7 cm) phase.To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely.the STAI FORM TX-I was used in the active (5-7 cm) phase in the control group and in the active (5-7 cm) phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour.

    Measured: 6 hours

Secondary outcomes (1)
  1. The Visual Analogue Scale (VAS) evaluated

    The Visual Analogue Scale (VAS) was used to measure the severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows: the absence of pain is indicated by "0", while the most severe pain is indicated by "10". In this method, it is explained to the individual that there are two endpoints and that he/she is free to mark any point that defines his/her pain.The VAS was applied to the participants in the control group once in the latent (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also applied to those in the experimental group once after the massage in each phase.

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start25 Jan 2016
  3. Primary completion25 Oct 2016
  4. Study completion25 Oct 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized and controlled experimental study
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03755284
Sponsor's protocol ID
Sacral Massage
Status last verified
Dec 2018
First submitted
20 Nov 2018
Last updated
7 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mortazavi SH, Khaki S, Moradi R, Heidari K, Vasegh Rahimparvar SF. Effects of massage therapy and presence of attendant on pain, anxiety and satisfaction during labor. Arch Gynecol Obstet. 2012 Jul;286(1):19-23. doi: 10.1007/s00404-012-2227-4. Epub 2012 Jan 21.

    PubMed 22271239
  • Abbaspoor, Z., Mohammadkhani, S.L. (2013). Lavender aromatherapy massages in reducing labor pain and duration of labor: A randomized controlled trial. African Journal of Pharmacy and Pharmacology, 7(8): 426-430. DOI: 10.5897/AJPP12.391.

  • Fenwick J, Staff L, Gamble J, Creedy DK, Bayes S. Why do women request caesarean section in a normal, healthy first pregnancy? Midwifery. 2010 Aug;26(4):394-400. doi: 10.1016/j.midw.2008.10.011. Epub 2008 Dec 30.

    PubMed 19117644
  • Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.

    PubMed 20479957
  • Silva Gallo RB, Santana LS, Jorge Ferreira CH, Marcolin AC, Polineto OB, Duarte G, Quintana SM. Massage reduced severity of pain during labour: a randomised trial. J Physiother. 2013 Jun;59(2):109-16. doi: 10.1016/S1836-9553(13)70163-2.

    PubMed 23663796
  • Bolbol-Haghighi N, Masoumi SZ, Kazemi F. Effect of Massage Therapy on Duration of Labour: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Apr;10(4):QC12-5. doi: 10.7860/JCDR/2016/17447.7688. Epub 2016 Apr 1.

    PubMed 27190898
  • Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.

    PubMed 23894767
  • Janssen P, Shroff F, Jaspar P. Massage therapy and labor outcomes: a randomized controlled trial. Int J Ther Massage Bodywork. 2012;5(4):15-20. doi: 10.3822/ijtmb.v5i4.164. Epub 2012 Dec 19.

    PubMed 23429706
  • Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

    PubMed 22419342

Questions about this trial

What is this clinical trial studying?

A study testing Sacral Massage in people with Labor Pain, run by Semra Çevik, phD 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 7 inclusion and 2 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 7 Dec 2018. 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?

The state-trait anxiety inventory (STAI FORM TX-I) evaluated (time frame: 6 hours). 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 NCT03755284, which also lists 9 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 7 Dec 2018.

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