Non-Pharmacological Method to Relieve Back Pain
Condition: Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The study will be carried out in a randomized controlled manner in order to examine the
      effectiveness of acupressure applied in the late postpartum period in postpartum women who
      have had back pain and have had a cesarean delivery. The sample of the study will consist of
      70 participants who applied to the family health center between 05.06.2023 and 05.12.2024,
      who had cesarean birth registered in the central family health center in Kocaeli province
      Kandıra district, who met the research criteria and agreed to participate in the research.
      Data in the research; It will be collected using the 'Participant Information Form', 'VAS
      (Visual Analog Scale for Evaluating Back Pain)', 'McGill Pain Questionnaire (Short Form)'.
      Participants in the acupressure group will be given 2 times acupressure application in the
      1st week and 4th week postpartum. No application will be made to the participants in the
      control group. The research is planned to be carried out after obtaining the necessary
      institutional and ethical committee permissions.
    

Detailed description: 
      Aim: The study was planned to examine the effect of acupressure on back pain in the late
      postpartum period after cesarean section.

      Hypothesis(s):

      H0: Acupressure application applied to puerperant women who had a cesarean delivery in the
      late postpartum period has no effect on reducing the level of back pain.

      H1: Acupressure application applied to puerperant women who had cesarean delivery in the late
      postpartum period reduces the level of back pain.

      Type of Research: This study was designed as a randomized controlled experimental study.

      Research Population: The population of the research will consist of participants who have had
      cesarean section, who have back pain, who are in the late postpartum 1st week and 4th week,
      and who are registered to family medicine units in a Family Health Center.

      It was calculated according to the research conducted by Akgün and Boz to determine the
      sample size in the study. The sample size of the study was calculated using the G*Power
      3.1.9.2 program and the mean, standard deviation values and effect size of the back pain
      variable in the related article (Akgün & Boz, 2020) were taken into account. The effect size
      was calculated as 1.025136 by using the mean and standard deviation values of the related
      article. The minimum number of individuals to be included in the sample of the study to be
      done was calculated by taking G*Power 3.1.9.2 and effect size: 1.025136, α= 0.05, power:
      0.90, and the sample size was determined as 23 in the acupressure group and 23 in the control
      group. A total of 70 (Acupressure group: 35, control group: 35 participants) participants
      will be included in the study, taking into account possible data losses.

      In which group the participants included in the study will be, will be determined from the
      website of the random number generation program "Research Randomizer", and they will be
      divided into two groups. Thus, each participants's number and group number will be determined
      and recorded.

      Data will be collected with the Introductory Information Form and VAS for assessing back
      pain.

      Introductory Information Form: The form consists of a total of 31 questions questioning
      women's sociodemographic, obstetric, pregnancy-birth and postpartum back pain information. It
      is applied to the puerperant women for the first time in the postpartum 1st week and the
      second time in the postpartum 4th week.

      VAS for Evaluation of Back Pain: The participant marks his or her own pain on a 10 cm ruler,
      which is marked as "no pain" at one end and the most severe pain at the other end. The
      participant is told that there are two endpoints and to mark any place between these points
      that matches the severity of the pain. The distance between the onset of no pain and this
      point marked by the patient is measured and recorded in centimeters. It is stated that VAS is
      more sensitive and reliable than other unidimensional scales in pain severity measurement.
      The VAS is more sensitive than the simple descriptive scale.

      After obtaining the necessary ethics committee and institutional permissions for the
      implementation of the study, participants who had a cesarean section and who met the
      inclusion criteria of the study will be interviewed by going to the institution. Participants
      will be informed that they can participate in the study without affecting the care received
      at the family health center and they can leave the study at any time, and their voluntary
      consent will be obtained. After the participants are included in the study, they will be
      assigned to the study groups according to the electronic randomization table. The data will
      be collected by the researcher through face-to-face interviews at the family health center.
      VAS (Visual Analog Scale) will be filled in by the participants to evaluate late postpartum
      back pain. VAS (Visual analog scale) in which back pain is evaluated will be filled in the
      acupressure group and control group for the first time in the postpartum 1st week and the
      second time in the 4th week before and after the application. No application will be made to
      the control group and only routine care will be given.

      An environment where privacy can be protected and away from external stimuli will be prepared
      for the participants. The application will be started by choosing the most comfortable
      position for the participants, leaving the application points open. For this study, 6 points
      (a total of 12 points on both sides from each point) were determined for this study, and
      these points are LI4, which is the 4th point of the large intestine meridian, Zhong Zu HT2
      point, which is on the triple heater meridian, and Quchi, the 11th point of the large
      intestine meridian. /LI11, the 36th point of the stomach meridian is ST36, the 21st point of
      the gallbladder meridian is Jian Jing GB21, the 43rd point of the bladder meridian is UB 43.
      In addition, expert opinion was taken to determine the points. The practitioner will apply 15
      seconds of warming, relaxing, and preparatory quality to the area of each of the notes,
      respectively, and lightly rubbing to reduce tension and tissue sensitivity. A total of 3
      minutes will be spent preparing for all points. After the preparation, acupressure will be
      applied to each point for a total of 12 minutes for all points for 1 minute. Thumb, index
      and/or middle finger will be used in acupressure application. Consecutive, breathing rhythm
      compressions will be repeated without raising the finger. Repeated compressions will be at a
      frequency that does not disturb the person, does not cause pain and has a calming effect.
      Although there is a difference in the order of use of the determined acupressure points, this
      study will be carried out symmetrically to the LI4, HT2, LI11, ST36, GB21, UB43 points,
      respectively. The practitioner will have a stopwatch to control the time.

      The data of the study will be evaluated using the Statistical Package for the Social Sciences
      (SPSS) 22.0 program. All data will first be evaluated with the Kolmogorov-Smirnov test for
      conformity to normal distribution, and then analyzed according to conformity to normal
      distribution. For descriptive statistics, percentages will be used in general, arithmetic
      mean±standard deviation for those suitable for normal distribution, median and
      minimum-maximum values for those that do not fit. Comparisons between groups for numerical
      variables of socio-demographic and clinical characteristics will be made with an independent
      two-sample t-test for normally distributed variables, and Mann-Whitney U test for
      non-normally distributed variables. Pearson Correlation test will be applied to determine the
      relationship between the fatigue severity of the experimental group and the tests and to
      determine the relationship between the tests. Statistical significance level will be accepted
      as p<0.05.
    

Intervention name(s): Acupressure group
Intervention type(s): Behavioral
Intervention description(s): Application to Acupressure Group
Participants in this group will be interviewed for the first time at postpartum week 1, and for the second time between 4-6 weeks postpartum. The application will be explained and a voluntary consent form will be signed.
Participant Information Form will be filled in by the researcher by face-to-face interview.
The VAS, which will be applied to the puerperant women for the first time in the first week of the postpartum week and for the second time between the 4th-6th weeks, will be filled by the participant just before the application to evaluate the back pain.
The VAS Evaluating Back Pain after the application will be filled in by the participant.
The participant will be informed that the study has been completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Back Pain; Late postpartum; Cesarean Section