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Trial record 34 of 287 for:    complementary and alternative medicine

Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax) (Hypnorelax)

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ClinicalTrials.gov Identifier: NCT02505100
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.

Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.

The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.

Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.

The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.

Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.

Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.

These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.


Condition or disease Intervention/treatment
Premature Birth Other: Touching relaxant Other: Hypnoses

Detailed Description:

The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.

Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.

The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.

Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.

The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.

Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.

Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.

These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)
Study Start Date : October 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: Touching relaxant
session of massage
Other: Touching relaxant
Experimental: Hypnoses
session of hypnoses
Other: Hypnoses
No Intervention: Standared care
standard care



Primary Outcome Measures :
  1. Number of weeks of gestation [ Time Frame: 4 months ]
    Term of delivery will be assessed



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant Patient hospitalized for the first time for MAP (preterm labor) at the Robert Debré hospital as defined in CNGOF (National college of French gynecologists and obstetricians):

    • frequent and regular uterine contractions (at least 3 in 30 minutes)
    • significant cervical changes,
    • before 37 weeks of amenorrhea (SA).
  • Single or multiple pregnancies
  • Age greater than or equal to 18 years
  • Patient between 24 + 0 and 32 + 0 weeks of gestation.
  • Patient not opposing its participation
  • Patient beneficiary of a social security

Exclusion Criteria:

  • Not understanding of technology (language barrier ...)
  • Psychiatric Pathology (cons-indication to hypnosis: schizophrenia, paranoia)
  • Refusal by the patient
  • Age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505100


Contacts
Contact: Céline Perrudin +33673851690 celine.perrudin@aphp.fr
Contact: Constance Borie, MD +33140034045 constance.borie@aphp.fr

Locations
France
Perrudin Recruiting
Paris, France, 75019
Contact: Céline Perrudin    +33673851690    celine.perrudin@aphp.fr   
Contact: Constance Borie, MD    +33140034045    constance.borie@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02505100     History of Changes
Other Study ID Numbers: PHRIP 1439287N
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
threat of premature birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications