Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2016-01-25
2016-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sacral Massage Group
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:
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.
Sacral Massage
● 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.
Control Group
There 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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sacral Massage
● 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
2. Pregnant women with a chronic illness were excluded.
19 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Semra Çevik, phD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Semra Çevik, phD
Assiatant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Semra Çevik, phD
Role: STUDY_DIRECTOR
University of Gaziantep
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gaziantep University
Gaziantep, Şahinbey, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan: statistical analysis
Document Type: Informed Consent Form: Informed Consent Form
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sacral Massage
Identifier Type: -
Identifier Source: org_study_id