NCT03755284

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

November 20, 2018

Last Update Submit

December 6, 2018

Conditions

Keywords

anxietylabor painmassagesurveys and questionnairesvisual analog scale

Outcome Measures

Primary Outcomes (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.

    6 hours

Secondary Outcomes (1)

  • The Visual Analogue Scale (VAS) evaluated

    6 hours

Study Arms (2)

sacral Massage Group

EXPERIMENTAL

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.

Other: Sacral Massage

Control Group

NO INTERVENTION

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

Interventions

● 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 Group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 22271239BACKGROUND
  • 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Semra Çevik, phD

    University of Gaziantep

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized and controlled experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assiatant Professor

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 27, 2018

Study Start

January 25, 2016

Primary Completion

October 25, 2016

Study Completion

October 25, 2016

Last Updated

December 7, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations